Clinical Trial Manager Job Description

A Clinical Trial Manager keeps a drug study on plan and on budget. At pharmaceutical and biotech sponsors, that work usually happens inside an outsourced model where CROs, central labs, and investigator sites execute the study while the manager holds each party accountable to the protocol, ICH-GCP, and the agreed scope of work. The hard part is timing. Enrollment slips, unresolved protocol deviations, and an incomplete Trial Master File all surface as threats to database lock and regulatory inspection in Phase I through III programs, where one delay can cost months of development time.

As the Clinical Trial Manager, you are accountable for delivering an assigned study on its timeline, budget, and quality targets so that clean data reaches database lock and supports regulatory submissions. You lead the cross-functional study team and direct CRAs and CTAs, typically within a Clinical Operations group that answers to a Director or Associate Director of Clinical Operations.

Career Impact: Carrying a Phase II/III study through closeout gives you the sponsor-side track record that Associate Director of Clinical Operations roles typically require.

Business Impact: Your oversight of CRO invoices and protocol deviations keeps the Clinical Study Report on schedule and Health Authority inspections free of major findings.

Growth Opportunity: Managing multi-country and first in human studies expands your scope toward global program leadership and Clinical Project Manager positions.

Company Value: Lean sponsor teams, some as small as four colleagues, give each manager direct influence on study strategy and departmental SOPs.

• Lead the cross-functional study team from start-up through closeout, keeping timelines and enrollment targets on track.
• Direct CRO and vendor selection, scope, and invoice review to ensure outsourced work matches contracted deliverables.
• Develop and control study budgets, timelines, and enrollment dashboards in partnership with finance and clinical leadership.
• Review protocols, informed consent forms, monitoring plans, and study manuals to ensure alignment with ICH-GCP.
• Monitor site performance through visit report review, protocol deviation tracking, and co-monitoring visits with CRAs.
• Own Trial Master File completeness and inspection readiness across sponsor, country, and site levels.
• Coordinate data review, query resolution, and drug supply planning to support on-time database lock.
• Mentor CRAs and CTAs on protocol requirements, SOPs, and site management practices within the study team.

• Bachelor's degree in life sciences, nursing, pharmacy, or a related scientific field or equivalent work experience.
• 3 or more years of clinical trial management experience, with sponsor or CRO exposure on interventional studies.
• Working knowledge of ICH-GCP, FDA regulations, country-level trial requirements, and inspection expectations.
• Demonstrated experience overseeing CROs and vendors against contracted scope, timelines, and budgets.
• Ability to manage study budgets, accruals, and site payments with accurate forecasting and variance reporting.
• Proven ability to lead cross-functional study teams and supervise CRAs or CTAs in a matrix environment.
• Skill in identifying study risks and building mitigation plans before they affect enrollment or data.
• Clear written and verbal communication with sites, sponsors, and internal leadership at all levels.

• Oncology or hematology trial experience, including early phase or first in human studies at a sponsor company.
• Management of global Phase I-III trials spanning multiple countries, regulatory authorities, and ethics committees.
• Hands-on experience running a trial from protocol writing and site feasibility through study closeout.
• Prior on-site monitoring experience as a CRA, supporting credible oversight of monitoring teams.

• Enrollment versus plan, showing how well recruitment strategy and site selection perform.
• Database lock date variance, reflecting data review and query follow-up discipline.
• Study budget variance, tracking control of CRO, vendor, and site spend.
• TMF completeness rate, measuring inspection readiness of study documentation.
• Open protocol deviations per site, indicating site oversight and CAPA follow-through.
• Monitoring visit report review cycle time, showing how quickly site issues are escalated.

• Base Salary Range: $120,000 to $160,000 depending on seniority and therapeutic area
• Bonus: Annual target of 10% to 15% of base salary
• Equity: Stock options or RSUs, most common at biotech sponsors
• Health Benefits: Medical, dental, vision, life insurance, and 401(k) with employer match
• PTO: 15 to 25 days plus paid company holidays
• Common Perks: Hybrid or remote work, certification support, and conference travel

Figures are estimates based on general US market benchmarks and may be outdated. Adjust based on location, company size, and seniority level.

Offers of employment are contingent on successful completion of a background check, which may include verification of education, prior employment, and clinical research credentials. Candidates must be authorized to work in the United States. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected by federal, state, or local law. Reasonable accommodations are available upon request throughout the hiring process.

The Clinical Trial Manager leads a clinical trial or region, managing budgets, timelines, vendor selection, and study sites from start-up through closeout to keep studies compliant and on schedule. Reporting within the clinical operations function, the Clinical Trial Manager supervises CRAs and CTAs and partners with the clinical contracting group so external service providers deliver quality work.

Key Responsibilities

• Manage study team activities, including investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and reports, consistent with approved budgets/timelines.
• Manage and/or oversee the management of study sites, ensuring protocol and regulatory compliance.
• Work with clinical contracting group in development of RFPs and vendor selection.
• Manage staff who oversee multiple vendors, including clinical services, data management, bio-statistical services, and central laboratory services, and ensure external service providers execute activities in a quality manner and per the established contract.
• Ensure SOP and regulatory compliance of staff and study teams on one or more trials.
• Participate in the development and review of study plans (e.g. CMP, DMP, SMP), study reports, protocols, ICFs, sections for Investigator's brochures, and other regulatory documents (e.g., IND, NDA or BLA) on one or more trials.
• Manage junior staff (CRAs, CRA IIs, CTAs) performing site management efforts.
• Manage investigational product and clinical supply needs.
• Assist with the coordination of data review with cross functional team to support database lock.
• Initiate and participate in leading departmental or interdepartmental strategic initiatives and process improvements.
• Manage team quality issues with investigational sites and/or vendors.

Required Qualifications

• Proficiency in the implementation, monitoring, and management of clinical trials.
• Demonstrated managerial and supervisory skills.
• Knowledge of GCP and ICH guidelines required.
• Strong computer skills in MS Word, Excel, Outlook, PowerPoint and Microsoft Project.
• Flexibility and ability to adapt to changing priorities.
• Excellent communication and interpersonal skills.
• Attention to detail and accuracy.
• Ability to problem solve and use good judgment.
• Ability to work independently and within a team.
• Ability to interact with customers, partners, coworkers internal/external to the department and/or company in accomplishment of business goals and objectives.
• High level of commitment and professionalism.

Embedded within one or more Study Management Teams, the Clinical Trial Manager delivers day-to-day trial management, from protocol and site feasibility assessments through enrollment dashboards and Trial Master File oversight. Working closely with vendors, clinical monitors, and trial sites, the CTM ensures high quality deliverables arrive within agreed timelines and budget.

Core Functions

• Manage day to day assigned operational aspects, such as CRO/vendor management, drug supply management, oversight of clinical sites, etc.
• Lead cross-functional SMT meetings.
• Participate in protocol, eCRF development, and Clinical Study Report preparation, as appropriate.
• Conduct protocol and site feasibility assessments.
• Participate in the selection of vendors, including CRO, central lab, imaging, etc.
• Oversee the development and review of study-related documents (e.g., eCRFs, Study Reference Binder, Study Management Plan, eCRF Completion Guidelines, etc.).
• Provide drug supply assumptions to the clinical planning team.
• Develop and maintain study timelines, enrollment dashboards, and budgets.
• Serve as a liaison and resource for clinical trial sites.
• Identify study risks, develop and implement mitigation strategies.
• Oversee the creation and maintenance of the Trial Master File.
• Perform site initiation, routine monitoring and close-out visits, co-monitor with CRAs as needed, and review site visit reports.
• Participate in initiatives and/or special projects, as assigned, and in the development, review and implementation of departmental SOPs and processes.

Qualifications & Experience

• Experience with international trials is preferred.
• Working knowledge of ICH Good Clinical Practice guidelines.
• Experience using computer applications including spreadsheets, email, word-processing software and web-based systems.
• Excellent planning and organizational skills.
• Able to handle multiple tasks and deadlines.
• Self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors.
• Highly effective verbal and written communication skills.
• Flexible and solution focused.
• Strong customer focus.
• Ability to build and maintain positive relationships with management, peers and clinical sites.

Reporting to clinical operations leadership, the Clinical Trial Manager shapes oversight of start-up activities, TMF quality control, and investigator and vendor payments across oncology studies at a small or mid-size company. Partnering with CROs, CRAs, and functional service providers, the Clinical Trial Manager keeps trials compliant, on budget, and ready for clinical study report review.

Primary Duties

• Assist in the tracking and oversight of all start-up activities (site and country study submissions, clinical trackers and essential documents status) and oversight of third party vendors.
• Participate in project management meetings, provide an overview of TMF status, clinical study administration, resources, quality, and workload on a regular basis, and communicate effectively with clinical study administration vendors (Functional Service providers etc.).
• Assist in coordination of Investigator and Vendor payments, tracking of payments and accruals, if applicable, and perform financial management, including review and approval of site and vendor invoices.
• Assist in data listing review and clinical study report listing review.
• Oversee monitoring activities at clinical CROs by reviewing visit reports, protocol deviations and CAPAs, and attend co-monitoring visits as required.
• Monitor study progress, ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs as applicable.
• Review and contribute to study Protocols, eCRF design and completion guidelines, pharmacy manuals, Informed Consent Forms, and other study-related documents.
• Coordinate/plan investigator meetings and/or site and CRA training.
• Track and coordinate trial related materials, including clinical trial supplies and laboratory samples.
• Perform review and QC of central clinical files and trial master file.
• Identify potential study issues and recommend and implement solutions or corrective actions as needed.
• Serve as a liaison and resource for investigational sites, review investigator contracts and site payments.
• Travel to CRO/vendor facilities and/or investigative sites to train and assess study team and CRAs.
• Participate in the development, review and implementation of departmental SOPs and processes.

Skills & Qualifications

• Bachelor's degree or equivalent in a scientific or health care field is required.
• At least 4-8 years of clinical trial management experience.
• Experience in CRO/vendor management, monitoring of budget scope, clinical site monitoring, and knowledge of basic data management/biostatistics processes and pharmacovigilance.
• Clinical operations experience at a small or mid-size company.
• Experience in running a trial from start to finish, including protocol writing, ICF generation, site feasibility/start up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out.
• Experience in clinical project management, vendor management, and oncology.
• Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint).
• Experience working independently and in a team environment, with flexibility and adaptability within a rapidly changing environment.
• Ability to multi-task, prioritize and manage time of daily activities.
• High attention to detail and high level of accuracy.
• Effective oral and written communication skills.
• Excellent ability to work in a goal and team-oriented setting.
• Well-developed organizational skills.

Sitting at the intersection of clinical monitoring and site management, the Clinical Trial Manager II shapes delivery quality for assigned studies through CTMS reviews, source data verification oversight, and risk-based monitoring plans. Operating across the Clinical Operations team, clients, and functions such as Safety and QA, the CTM II mentors staff and supports inspection readiness while protecting the financial goals of each project.

Duties

• Support primary study Clinical Lead in routine reviews of CTMS, CRF, drug management, safety, TMF, IVRS/IWRS enrollment, Data Visualization dashboards (where available) to oversee site and study team conduct and ensure timely entry of all operational aspects (required visits/calls, duration, and frequency) according to plan.
• Oversee assigned site and study team members' conduct, identify risks to delivery or quality, and ensure quality of clinical monitoring and site management deliverables with proper visibility of progress through approved systems and/or tracking tools.
• Understand the monitoring strategy required for the study and, where required, participate in the development of the study risk assessment plan.
• Take accountability for assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans.
• Review the content and quality of site monitoring documentation (site monitoring calls, site visit reports, site letters, and pertinent correspondence) and ensure these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines.
• Interact with the client and other functional departments related to clinical monitoring and site management activities and deliverables.
• Demonstrate understanding of other functions' roles, such as medical monitoring, Safety and QA, in achieving site compliance and delivery according to protocol, ICH/GCP and/or GPP and country regulations, and support Inspection Readiness for Clinical Scope.
• Understand budgeted clinical activities to identify out of scope activities and support study tool and template development.
• Deliver initial and ongoing training to the study team regarding protocol specificities, CRF completion, Sponsor SOPs, clinical plans and guidelines, data plans and timelines for the study.
• Oversee assigned clinical staff routinely to assess site processes, review all Source Documents and medical records, perform SDR and/or SDV per the CMP/SMP, and review identified and newly emerging risks.
• Develop and support execution of corrective action plans at site and study level per the risk based monitoring strategy in the CMP/SMP, as needed, and support and complete activities to achieve data cut and lock deadlines.
• Evaluate staff's competency to perform visits/site contact independently via sign-off visits and Performance Assessment Visits (PAVs) according to company standards and process, as needed.
• Proactively engage in feedback opportunities that support BU level initiatives.

Requirements

• Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
• Demonstrated capability of working in an international environment.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Demonstrated learning of basic clinical project financial principles.
• Ability to apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.
• Good computer skills.
• Demonstrated ability to lead and align teams in the achievement of project milestones.
• Good communication, presentation and interpersonal skills among project team and with sites.
• Ability to apply problem solving techniques to resolve complex issues.
• Critical thinking to determine the cause and appropriate solution in the identification of issues.

A key member of the country operations team, the Clinical Trial Manager leads patient recruitment strategy, CAPA development, and database lock coordination across three countries. Collaborating across global study teams, CROs, and local Health Authorities, the Clinical Trial Manager helps assigned trials meet enrolment targets and remain inspection ready.

Functions

• Coordinate country cross functional teams and act as the main point of contact for the 3 countries with the protocol manager and other global study team members.
• Coordinate with other internal roles in the country and site feasibility process, including proposal and validation of country study targets.
• Develop country level patient recruitment strategy and risk mitigation, and ensure country level study enrolment targets and timelines are met.
• Lead problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s.
• Assess and set up vendors during study start up period (locally).
• Participate in and prepare Investigator Meetings, prepare materials for Site Initiation Visits, and lead study team meetings locally.
• Ensure data entered in Clinical Trial Management Systems is current and complete and access to eDC and vendor systems is available for the Country and clinical trial site personnel.
• Validate study related materials (protocol, ICF, patient material) and prepare country specific documents (e.g. global country specific amendment).
• Verify and confirm with local team eTMF completeness (Country and Site level).
• Review Site Monitoring visit reports, take action within the timelines specified, escalate issues and ensure appropriate documentation of issues.
• Coordinate database locks and query follow up, ensuring timelines are met.
• Ensure inspection readiness of assigned trials within country, support Health Authority inspection and pre-inspection activities, and coordinate, develop and write CAPA for Country audit level findings, driving review, implementation and completion.
• Review and approve payments (based on GOA), manage patient compensation claims (if applicable), and manage Site relationships (including CRO related issues) as point of contact for Sites.
• Conduct PSEVs and SIVs, perform site closure activities including post-close out, and support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instances.

Experience & Qualifications

• Bachelors or Masters Degree within pharmacology or life sciences field or equivalent.
• Minimum 4 years' industry related experience.
• Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives.
• Understanding of GCP, ICH Guidelines and Country regulatory environment.
• In depth knowledge and understanding of Clinical Research and Clinical Trials processes, regulations and methodology.
• Understanding of clinical landscape with practical knowledge of a variety of medical settings and medical records management.
• Critical thinking and risk analysis ability.
• Skilled in the use of technology, including CTMS, eDC and eTMF.
• Demonstrated organizational and planning skills and independent decision-making ability.
• Strong time management skills and ability to effectively manage multiple competing priorities.
• Strong communication skills with a strong customer focus, able to manage both internal and external clients at all organizational levels.
• Good verbal and written communication skills in both English and Italian.

Reliable, up to date clinical trial data for early phase oncology programs depends on the Clinical Trial Manager, who builds and coordinates the Clinical Trial Team across multi-country studies, from site selection to protocol deviation oversight. Serving as a reference figure in a four-person team reporting to the Head of Clinical Operations, the Clinical Trial Manager liaises with CRAs, Data Managers, and Regulatory Affairs to support correct trial implementation.

Accountabilities

• Assess the feasibility of projects from an operational point of view, where applicable.
• Coordinate and lead the Clinical Trial Team (CTT) ensuring the availability of documentation for meetings, and liaise with e.g. CRA, Data Manager, PV Manager, Regulatory Affairs Manager, etc. for study related activities.
• Participate in the Company cross-functional meetings, interface with and supervise contractors, collaborators and any party involved in assigned CO activities, if applicable.
• Contribute to the selection of investigator/investigational sites according to project requirements.
• Advise on the project-specific budget for investigators/investigational sites and related contractual arrangements.
• Assist in the preparation of clinical trial (CT) documents for initial submission to regulatory authorities and IEC/IRBs and subsequent maintenance.
• Ensure the preparation and update of study manuals and plans, and the preparation, maintenance and archiving of study documentation.
• Perform study set-up, review and maintenance in Veeva system (e.g. account management, periodic review).
• Provide project-specific training or retraining to relevant persons where appropriate, and supervision of project related monitoring activities.
• Perform oversight on protocol deviations that occurred during the conduct of the study, contribute to assess their impact and liaise with the function and sites concerned for corrective/preventive actions.
• Contribute to IMP related activities and to the management of drug recalls and other urgent safety measures, as appropriate.

Technical Qualifications

• Scientific degree (Biology, Pharmacy, Chemistry).
• Experience, preferably at least 5 years, gained in Clinical Trial Manager/Clinical Project Manager positions in early clinical development of oncology compounds in pharmaceutical companies or CROs, Biotech, etc. with responsibility for multi-country trials.
• Ability to carry out technical-economic feasibility analyses of requests.
• Project management skills.
• Excellent organizational, planning and problem-solving skills.
• Good interpersonal and excellent relationship skills, with habit/aptitude for working in complex and international contexts.
• Team working orientation, engagement and aptitude for cross-functional team working.
• Ability to act on several fronts at the same time and sense of responsibility.
• Fluent knowledge of the English language, written and spoken.

As the Clinical Trial Manager, this role owns operational support for Phase II/III studies, spanning site selection, CRO oversight, study level budgets, and inspection ready eTMFs. The Clinical Operations department relies on this work, guided by the Director Clinical Operations, to set realistic timelines, protect data quality, and support the company's growth.

Activities

• Support the study feasibility and site selection process in conjunction with the Director Clinical Operations.
• Develop study operational strategies including vendor outsourcing approach in collaboration with Director Clinical Operations.
• Assist with management of CROs and third-party vendors in line with study and program goals, including reporting metrics.
• Review study plans and documents to ensure compliance with GCPs, vendor and in-house procedures.
• Participate in site initiation visits.
• Assist clinical sites with questions and resolving queries.
• Ensure complete and inspection ready eTMFs throughout the duration of clinical trials.
• Support management of study level budgets.
• Support development and follow through of effective clinical and safety data review plans throughout the study, as well as development and implementation of corrective action plans to ensure good data quality.
• Provide support to the multifunctional team and manage vendors, with oversight from the Director, Clinical Operations, to develop aggressively realistic timelines and ensure appropriate accompanying risk mitigation plans.
• Create and improve upon business processes to ensure the company's successful growth.

Position Requirements

• BA/BS in a clinical or scientific discipline.
• At least 3 years of experience with clinical trials working with a sponsor company (biotech/pharmaceutical company) and at least 3 years of project management experience.
• Required Phase II/III and international clinical trial management experience, with Endocrinology/Immunology trial experience and rare disease experience a plus.
• Required experience managing CROs for full service trials and managing all aspects of clinical trial from start-up, maintenance, through closeout.
• Required experience managing and coordinating multiple internal and external workstreams such as EDC, IWR, eCOA, Clinical Drug Supply, Risk based monitoring, Pharmacovigilance, Labs, Clinical monitoring.
• Understanding of FDA, EMEA, ICH and GCP guidelines, as well as cross-functional clinical processes including clinical supply, data management, biostatistics, medical writing, drug safety, regulatory affairs, and legal considerations.
• Deep understanding of clinical trial operations and management of clinical trials at investigator sites.
• Multitasking ability to oversee a large number of tasks/projects and reach milestones on time.
• Exceptional academic and professional accomplishments, indicating critical thinking ability.
• Strong written and oral communication skills with incredible attention to detail.
• Willingness to roll up your sleeves and get in the weeds of projects as a jack of all trades, with ability to think outside of the box and challenge the status quo.
• Natural entrepreneurial spirit with unrelenting dedication to delivering results and desire to work in a fast-paced, innovative environment.
• Natural collaborator who enjoys working on a cross-functional team.

Clinical Trial Manager II delivers study documentation quality across multiple clinical vendors, including TMF content review, protocol registration compliance, and CSR appendix assembly at close-out. The work directly supports the CPL, CROs, and cross-functional teams by keeping study plans, budgets, and investigator portal access aligned with regulations and SOPs.

Operational Focus

• Customize/update any study-specific plans and process flows for multiple clinical vendors, as appropriate e.g., TMF Plan, site training plan, site monitoring plan, cross functional data review plan, IP release plan etc.
• Ensure quality of the trial master file through content (QC) review of document packages submitted for entry into the TMF and liaise with project teams to resolve any issues identified.
• Assist CPL by tracking compliance to all study level plans and escalating any variances.
• Serve as system expert and point of contact for business technologies used during the study (e.g., EDC, Investigator Portal, TMF), and coordinate study team training in the investigator portal, monitoring site/CRA user access and tracking compliance.
• Ensure CRA compliance with the study parameters via review of monitoring visit reports and track escalation and closure of action items noted in them.
• Ensure registration of a protocol in ClinTrials.gov/EUdract, monitor its update throughout a study's life cycle for compliance with the regulations and SOP, and act as central point of contact for the vendor providing this service.
• Assist CPL with interactions with CRO and site staff to adhere to study budgets, request accruals and perform contract and invoice review.
• Participate in operation meetings with CRO and cross-functional team members, documenting escalations and actions.
• Coordinate with CPL and cross-functional team to assemble study documents as appendices for CSR at study close-out.
• Prepare subject files, inventory documents, reconcile document discrepancies, and organize study files for electronic archive and off-site storage upon site closure.
• Serve as SME for initiatives in conjunction with the CoE, as required, to ensure consistent implementation of best practices across all studies and within a franchise.

Knowledge Skills & Abilities

• Bachelor's degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development.
• Research certification desirable.
• More than 3 years of clinical research experience in the pharmaceutical industry with a solid understanding of technology and processes used in drug development.
• Experience working with CROs and vendors to drive timelines and deliverables.
• Experience working with study budgets and forecasting, contract and invoice review.
• Ability, with or without an accommodation, to use a computer and engage in communications via phone, video, and electronic messaging.
• Ability to engage in problem solving and non-linear thought, analysis, and dialogue, and collaborate with others.
• Duties generally conducted in an office environment, with general availability during standard business hours.

The Clinical Trial Manager oversees allocated studies across therapeutic areas, coordinating functional departments and vendors to hit milestones, timetables, and quality standards. Reporting to the CTM Director, the Clinical Trial Manager acts as principal liaison with Sponsors and strengthens client confidence through timely updates and disciplined escalation.

Key Deliverables

• Manage allocated studies according to timelines and quality standards, coordinating activities of all functional departments and vendors involved in the project.
• Work with team and management to develop plans/guidelines for project implementation using company tools.
• Monitor and analyze project status to ensure successful completion of project parameters, milestones, timetables, and ensure teams are entering and updating internal tracking tools.
• Work with team to identify potential risks and develop contingency plans.
• Act as principal liaison between Sponsor and the company by facilitating the flow of information between the company and client.
• Provide Sponsor with timely project updates, ensure correct protocol interpretations, obtain direction and feedback on implementing scope of work, and discuss and obtain feedback regarding the company's performance to date, where applicable.
• Plan and communicate study specific tasks and priorities for projects to team members and delegate assigned responsibilities as appropriate.
• Liaise with managers in all functional areas within the company to optimize performance and utilization of the project team members.
• Escalate any issues or potential issues to the CTM Director and Customer and serve as success lead for all project related issues.
• Ensure appropriate assessment and coordination of project/protocol specific and therapeutic area training needs and activities for team members as needed.
• Provide input into hiring, performance management, training and other activities related to leading project staff members across functional areas.
• Schedule, lead and follow up on pre-identified internal and/or external meetings.
• Provide recommendations and alternative resolutions to project-specific challenges through established escalation channels, ensure guidelines and processes are followed for efficient escalation of out of parameter issues, and escalate identified findings from periodic quality reviews and peer feedback reports.

Professional Experience

• Bachelor's degree.
• 5+ years experience in the clinical trial/pharmaceutical industry.
• Experience in project management.
• Experience with oversight of external vendors (e.g. e-consent vendor).
• Experience collaborating and leading cross-functional teams in a matrix environment.
• Experience managing multiple projects across various therapeutic areas.
• Experience anticipating and resolving problems on projects.
• Experience reporting project details to various stakeholders within company and outside of the company.
• DCT experience a plus but not required.
• Site experience a plus but not required.

Embedded within a growing clinical operations department, the Clinical Trial Manager oversees day-to-day operations of one complex or several smaller trials, including IVD device and molecular assay studies. Working closely with cross-functional colleagues, vendors, and clinical site personnel, the Clinical Trial Manager holds deliverables to timeline and budget while mentoring junior staff and upholding GCP and healthcare compliance.

Areas of Ownership

• Manage day-to-day operations of one complex or multiple smaller clinical trials, ensuring all trial deliverables are met according to timelines, budget, quality standards and operational best practices.
• Manage all study related documents (protocol, ICF, CRF, contract, budget).
• Ensure compliance with study protocol, scope of work and corporate timelines, identify areas of concern and escalate, as appropriate.
• Track overall study status, assess risks, and develop mitigation strategies.
• Inform management of recruiting issues and propose solutions.
• Participate in clinical data review of data listings and summary tables, including query generation.
• Monitor trial progress/timelines to ensure compliance with and adherence to the project plan.
• Participate in vendor selection, oversee vendors and contribute in any internal or external audits.
• Interact with cross-functional team members on sample and data analysis to maintain compliance, GCP, data protection and ethical requirements.
• Ensure local and global healthcare compliance policies are followed.
• Participate in clinical trial protocol development, site selection etc.
• Manage or mentor junior clinical operations staff as department grows.

Background & Experience

• More than 5 years of clinical operations and/or clinical trials experience or similar (CRA/CTM).
• Highly desired experience with IVD device and/or molecular assay studies.
• Knowledge of emergency medicine, ICU medicine or infectious diseases a plus but not required.
• Ability to use Microsoft Office Suite (Word, Excel, PPT), Adobe Acrobat Reader DC, and EDC systems.
• Excellent verbal and written communication.
• Efficient time management and organizational skills.
• Ability to constructively interact directly with clinical site personnel.
• Excited to 'wear many hats' and self-motivated to take on new challenges.
• Track record of success in a deadline-driven and multi-task environment.
• Attention to detail and accuracy in work.

Reporting to Regional Clinical Trial Operations leadership, the Clinical Trial Manager oversees protocol delivery as Regional Protocol Lead, spanning site selection, vendor processes, and Trial Master File completeness. Partnering with CROs, the quality function, and sponsor cross-functional staff, the Clinical Trial Manager secures inspection readiness for global Phase I-III studies under CFR and ICH/GCP.

Role Responsibilities

• Act as Regional Protocol Lead and serve as main point of contact for clinical site management.
• Collaborate with internal team members, Contract Research Organizations (CRO), vendors and sites.
• Assist with design and review of protocols/informed consent forms (ICFs) and other study documents.
• Lead identification, evaluation, and selection of clinical trial sites.
• Coordinate and manage vendor processes.
• Take accountability for tracking of ancillary and investigational supplies, specimens and/or imaging.
• Facilitate communication between sites and the sponsor's cross-functional staff.
• Lead functional teams within Regional Clinical Trial Operations.
• Take accountability for completeness of Trial Master File (TMF).
• Work closely with quality function to ensure inspection readiness and support audit and/or inspection activities.
• Serve as primary point of contact for CRO activities.
• Ensure training compliance of all staff.
• Contribute to process improvement initiatives and departmental projects.
• Perform all duties and responsibilities in accordance with CFR, ICH/GCP Guidelines, SOPs, and other applicable guidelines.

Minimum Qualifications

• Minimum of 5 years of relevant clinical trial management experience.
• Oncology clinical research experience is preferred.
• Global Phase I-III trial management experience.
• CRO management experience.
• Experience managing large teams (direct or dotted line reporting).
• Knowledge of CFR and GCP/ICH requirements as well as European Clinical Trial Directive.
• Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (eg, CTMS, EDC and eTMF).
• Excellent leadership, communication, and organizational skills.
• Ability to proactively handle multiple tasks, manage a diverse range of functional activities and solve problems simultaneously.
• Strong communication and inter-personal skills.
• Highly responsive and proactive, a team player.

Sitting at the intersection of medical device regulation and clinical operations, the Junior Clinical Trial Manager advances trial progress through TMF review, CRO tracking, clinical budget tracking, and site selection support. Operating across CRO monitors, management, and cross-functional areas, the Junior Clinical Trial Manager moves each trial toward its goals under GCP, ISO, and internal quality requirements while mentoring CTAs.

Job Functions

• Ensure that clinical trials are conducted per the protocol, country regulations, Good Clinical Practice regulations, internal Standard Operating Procedures, and applicable Quality System requirements.
• Participate in the writing of clinical documents and the study execution plans.
• Lead TMF review and tracking of CRO.
• Ensure the progress and completion of the trial(s) in-line with trial goals.
• Participate in feasibility assessment, potential investigator identification, and site selection.
• Prepare study-specific tools (including communication tools such as newsletters, flyers, etc.) and trial-specific updates for management and cross-functional areas.
• Participate in the planning, implementation, and tracking of clinical budgets, review vendor invoices and approve investigator grants and pass-through costs.
• Organize and participate in investigational meetings and site training representing assigned clinical trial.
• Participate in the preparation and follow-up of in-house and on-site sponsored quality audits, co-monitoring visits with CRO monitors, as well as regulatory authority inspections.
• Train and mentor clinical operations team members such as CTAs and Sr. CTAs.

Education & Experience

• Bachelor's degree preferably in Nursing, Medicine or other Life Sciences, or RN degree from an accredited school or equivalent.
• Minimum of 4-year experience working in different positions in the field of clinical trials, including CRA-level experience (both CRO and industry experience are acceptable).
• Experience as CRA (working for CRO or sponsor company) would be an advantage.
• Experience leading Clinical Trial Processes.
• Experience in review and tracking of regulatory documentation for successful implementation of clinical trials.
• Familiar with regulatory affairs, Medical Device regulations, clinical trials and ISO.
• Working knowledge of ICH/GCP.

A key member of the clinical operations organization, the Clinical Trial Manager oversees trial activities from startup to reporting, covering documentation, risk management, trial budgets, and sponsor oversight. Collaborating across CROs, internal stakeholders, and Compound Development Teams, the Clinical Trial Manager secures deliverables for oncology and first in human studies.

What You'll Do

• Lead the trial team and act as the overall responsible person for trial related activities from startup to reporting of a clinical trial in close collaboration with internal stakeholders and CROs.
• Secure trial deliverables in a proactive and motivational manner.
• Communicate with and perform stakeholder management of CROs and other stakeholders throughout all stages of trial conduct.
• Create a good working environment by being a role model and a great team member.
• Ensure proper documentation, record management, risk assessment/management, trial budgets as well as sponsor engagement and sponsor oversight activities.
• Constantly develop and implement new and better clinical trial practices.
• Act as Clinical Operations representative in Compound Development Teams.

Required Qualifications

• BSc or MSc level within the medical, biological, pharmaceutical science or equivalent.
• Minimum 3-4 years experience with clinical trial management from a pharmaceutical company and/or CRO.
• Experience within the field of oncology and/or first in human trials is preferred.
• Minimum 2 years of experience as Clinical Operations representative in Clinical Development Teams (CDTs) or Global Project Teams (GPTs) would be preferable.
• Proven skills from working in a project oriented and international organization.
• Dedicated team player who enjoys leading teams and inspiring trust among colleagues.
• Quality mindset and ability to prioritize your work in a fast-paced and changing environment.
• Result- and goal-oriented and committed to contributing to the overall success of the company.
• Excellent communication skills in English both written and spoken.

Contracted site management and monitoring delivery depends on the Clinical Trial Manager, who oversees project finance, vendor management, and status reporting for assigned projects. Serving as leader of the site management and monitoring team, the Clinical Trial Manager reports progress to Project Managers and clients and aligns delivery with GCP and ISO standards.

Day-to-Day Responsibilities

• Lead, train and mentor the site management and monitoring team.
• Deliver contracted services relating to aspects of site management and monitoring for assigned projects.
• Optimise vendor management activities applicable to site management and monitoring areas of allocated projects.
• Manage project finance.
• Track and report on site management and monitoring status to Project Managers and clients as required.
• Ensure that the project delivery is in accordance with GCP, ISO, internal procedures, applicable regulations and standards and project specific documents.

Qualifications & Experience

• Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines (MSc or PhD is highly desirable).
• 5+ years of experience of on-site monitoring of clinical trials as a CRA is required.
• Exposure to a broad range of trials across multiple therapeutic areas.
• Oncology experience is preferred.
• Solid understanding and knowledge of appropriate therapeutic indications as they relate to the conduct of clinical trials.
• Sound knowledge and understanding of ICH-GCP.
• Demonstrated ability to lead a team.
• Ability to work independently.

As the Clinical Trial Manager, this role develops the Protocol Management Plan, study budgets, and risk-based monitoring approach for epidemiology studies and clinical trials in global health. The Clinical Operations group, led by the Associate Director, relies on this work to deliver trials on time, within budget, and in line with ICH GCP and FDA regulations.

Scope of Work

• Develop the Protocol Management Plan (PMP) and coordinate the development of operations plans for all applicable functions for inclusion in the PMP.
• Develop study timelines, ensure adherence, and escalate concerns/issues related to timelines to senior management appropriately.
• Lead clinical trial team meetings and contribute clinical updates to cross-functional project team meetings.
• Oversee the evaluation, development, set-up, training, and monitoring of investigational sites participating in epidemiology studies and clinical trials.
• Develop and control study budgets with oversight from the Associate Director, Clinical Operations, working with other departments as appropriate to ensure execution within budget, and escalate budget concerns/issues to senior management appropriately.
• Assist the Associate Director, Clinical Operations in determining which services will be conducted by the organization and which will be outsourced, and in the identification, evaluation and selection of CROs and other vendors.
• Proactively anticipate risks, plan for and implement risk mitigation strategies throughout the trial conduct while keeping senior management informed, and actively manage issues that could impact study progress, taking actions or making recommendations to support compliance.
• Coordinate and develop study protocols, Informed Consent Documents, Study Operations Manual, monitoring plan, tracking forms, and other study related documents as required.
• Lead implementation of risk-based monitoring for assigned studies and review and approve monitoring visit reports submitted by CRAs.
• Complete monitoring oversight visits as needed to review clinical data for accuracy and completeness and resolve discrepancies in accordance with the study monitoring plan.
• Maintain good relations with the organization's collaborators and trial sites to facilitate site development and execution of clinical trials.
• Mentor and train Clinical Operations Specialists, CRAs and Clinical Trial Associates, as needed.
• Delegate clearly defined clinical trial management activities to the COS when assigned a trial with a Clinical Operations Specialist, ensure deliverables are met with appropriate timeliness and quality, and mentor and provide training to the COS as needed.
• Contribute to the CD departmental SOPs for conduct of clinical trials based on the organization's templates, ensure adherence to regulations/guidelines for GCP, and serve as a member of the CD SOP task force as needed.

Skills & Qualifications

• Bachelor's degree in a scientific or related field is required, and an advanced degree is highly preferred.
• Minimum 5 years of relevant experience in clinical trial operations, including at least 2 years in clinical trial management or equivalent experience at study sponsor.
• Familiarity with HIV, TB, emerging infectious diseases and/or global health is highly desirable.
• Expert knowledge of clinical research operations, Good Documentation Practices, ICH GCP, FDA CFR and other relevant regulations as well as Declaration of Helsinki and relevant country-specific regulations.
• Strong project management skills and the ability to deliver on assigned tasks within deadlines.
• Familiarity with electronic document management systems such as Veeva and electronic data capture systems, with excellent computer skills in software tools needed for the position.
• Proven ability to lead multi-disciplinary clinical trial teams effectively to deliver clinical trials at high quality, on time and within budget, and to mentor other clinical operations staff.
• High level of interpersonal skills and ability to work effectively with outside vendors, collaborators, subordinates and functional peer groups at various management levels.
• Ability to work on problems of high complexity and diverse scope using good judgment within defined procedures and policies to determine appropriate action.
• Flexibility to change priorities and comfort with changing deadlines to meet organizational needs.
• Detail-orientated, with the ability to work independently on multiple projects/tasks with overlapping schedules and priorities.
• Excellent oral and written communication skills, including ability to conduct presentations of technical information concerning specific projects and to be an effective trainer.
• Ability to work collaboratively with people of diverse educational and cultural backgrounds and maintain a high standard of professional conduct as a representative of the organization.
• Commitment to following all company safety practices, SOPs and policies.

Contract Clinical Trial Manager oversees all operational aspects of one or more clinical studies, from protocol development and TMF set-up through database lock and study closure. Success in the position means guiding a multi-functional study team, CROs, and vendors to meet timeline, budget, and ICH/GCP quality standards while keeping the study inspection ready.

Work Activities

• Contribute to the execution of clinical trials and drive to solutions across a multi-functional study team.
• Anticipate and resolve complex and key technical, operational or business problems with the multi-functional study team, evaluating and determining issues that require escalation.
• Use performance metrics and quality indicators to drive study execution.
• Support Health Authority inspections and CQA audits as required, including driving inspection/audit readiness through life of study.
• Collaborate with study team and/or CRO to ensure completeness and accuracy of the required data in study management tools including clinical trial management systems, patient enrollment forecasting, etc.
• Proactively identify potential risks and lead the development/implementation of actions to avoid or mitigate, identifying points for escalation.
• Collaborate with vendors and other study team members regarding study specific issues.
• Lead and/or collaborate in the creation and review of study documents, including the Protocol, ICF and other patient facing materials, case report forms, and clinical study reports, managing their timely completion and updating them as needed throughout the trial.
• Plan site and country identification and selection in collaboration with internal partners.
• Manage and/or participate in vendor selection, specification development and management/oversight, as appropriate per vendor/scope of work.
• Ensure management of the TMF set-up, ongoing quality review, and final reconciliation.
• Liaise as needed with CRO and investigative sites to ensure clinical trial data is captured and resolved, and contribute to data review/cleaning of clinical data as defined by study plans.
• Manage the development/coordination of study training and study training materials for study team, investigational sites, and vendors.
• Contribute to oversight of the required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC submissions/approvals/notifications, and ensure collection of study documents such as country/site insurance, CSR appendices, etc.

Requirements

• BA/BS degree in a relevant discipline.
• 5+ years' experience in clinical drug development required, with Oncology and/or Hematology and/or Clinical Pharmacology/Healthy Volunteer experience preferred.
• Experience in managing global clinical trials preferred.
• Experience with managing clinical research budgets.
• Experience with managing a multi-functional team, including leadership skills and driving deliverables.
• Knowledge of ICH/GCP and regulatory guidelines/directives, and of the drug development process.
• Strong knowledge of MS applications including MS Project, Word, Excel, PowerPoint, and study tools including CTMS/EDC/IRT/eTMF.
• Analytical approach and anticipation of problems, identifying gaps and providing constructive feedback and solutions.
• Follows issues to resolution and escalates as appropriate.
• Ability to multi-task effectively and prioritize assignments from multiple sources, with excellent organizational skills.
• Strong communication skills, both written and oral.
• Proactively shares information, ideas, input, and/or expertise with team members and demonstrates concern for high quality outcomes.
• Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute.
• Proficiency in English.

The Clinical Trial Manager coordinates multinational trial execution within an outsourced CRO model, managing timelines, budgets, site selection, and recruitment plans. Reporting to Development Operations leadership, the Clinical Trial Manager serves as primary contact between Drug Development and other departments to deliver trials with the highest achievable quality.

Performance Expectations

• Ensure adherence to Good Clinical Practice and all applicable local and international regulations.
• Deliver Trial(s) on time, within budget, and with highest achievable quality, developing and managing trial(s) timelines, budget and project milestones.
• Manage the conduct of clinical Trial(s) and provide operational leadership within an outsourced, CRO model.
• Assist in the review, development and/or writing of clinical trial documents and manuals, including Protocol, Case Report Forms, informed consent forms, Clinical Study Report and other regulatory documents.
• Manage the evaluation and selection of investigative sites.
• Select, coordinate and monitor activities of CRO and associated vendors, and perform initial review of their invoices to ensure work is performed in accordance with scope of work.
• Review monitoring reports and conduct co-monitoring visits, as needed.
• Participate in data management activities, including data review and discrepancy resolution, and in monitoring study safety.
• Ensure set up and maintenance of all systems that implement trial(s), track progress throughout the program, and generate reports to update leadership on conduct of trial.
• Ensure appropriate clinical trial supplies are ordered in time and supply plans are implemented and managed.
• Develop recruitment plans and risk-mitigation plan, monitor, and implement contingencies as required.
• Develop key study quality metrics (e.g., protocol deviations per site, number of queries per site, number of SOP deviations for the study, number of data base migrations etc) and determine appropriate action in conjunction with study team.
• Assist the Clinical Scientist, Medical Monitor, CRA and other third party vendor training on protocols and practices, lead operational study team meetings, and function as the primary contact for trial(s) between Drug Development and other departments.
• Participate as a member of working groups and perform special projects, as assigned, to improve the efficiency, effectiveness and quality of the Development Operations Department.

Experience & Qualifications

• BS/BA degree or a relevant degree with strong emphasis on science.
• Minimum of five years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials.
• Able to manage complex and/or large trials, with demonstrated ability in an outsourced, CRO model a plus.
• Experience in executing a wide range of clinical trial activities (from initiation to clinical study report).
• Working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience.
• Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously.
• Leadership, critical thinking, time management and problem solving skills.
• Used to working in a multidisciplinary setting, strong cooperative team player, able to be flexible and adapt to a changing environment.
• Good planning, prioritization, problem solving and organizational skills.
• Strong customer-orientation, used to working independently.
• Strong communication skills, used to communicating with a broad range of stakeholders and building strong positive relationships.

Embedded within Clinical Operations under the Director, the Clinical Trial Manager executes traditional and decentralized studies, from protocol and recruitment strategy development through IRB approval, clinical monitoring, and database lock. Working closely with Science, Medical Affairs, Product teams, CROs, and sites, the Clinical Trial Manager drives study decisions that keep outcomes, budgets, and timelines on track.

Core Responsibilities

• Design and execute a variety of clinical study designs.
• Assume overall responsibility for development of protocols, recruitment strategies and mitigation activities to increase patient randomization, monitoring plans and data management oversight, IRB/Ethics committee approval and management of vendors and study site trial contracts.
• Participate in protocol, CRF and strategy development, Clinical Study Report preparation, IDE submission and publications, as appropriate.
• Collaborate cross-functionally with Science, Medical Affairs, and Product teams and act as the point of contact for all external and cross functional teams.
• Prepare metrics and updates for management.
• Proactively identify potential study issues/risks and recommend/implement solutions.
• Participate in and facilitate CRO/vendor selection process for outsourced activities.
• Identify and coordinate study specific training for clinical staff and cross functional personnel for protocol execution, CRF completion, adverse event reporting and pharmacovigilance.
• Manage clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations.
• Recommend and implement innovative process ideas and novel recruitment strategies to impact clinical trials management.
• Organize and manage internal team meetings, investigator meetings and other trial-specific meetings.
• Take responsibility for the financial management of the clinical trial in conjunction with the finance department and establish procedures to ensure adherence to trial protocols, administrative requirements, timeline milestones.
• Provide regular and ad hoc information, both written and verbal, to internal/external teams, including reports, updates, guidance, preformed commitments and, possibly, a site newsletter.

Technical Qualifications

• Bachelor's Degree required/Advanced Degree preferred in life sciences, health care or related discipline.
• Trial Manager experience 2+ years in biotech, pharma, or CRO setting is a minimum requirement.
• Experience with commercial IRBs (e.g. WIRB, Advarra).
• Working knowledge of Good Clinical Practice (GCP) and national and international regulations for clinical trials.
• Advanced written, oral, and interpersonal communication skills, including proficient knowledge of medical terminology.
• Ability to deliver results and execute on required activities individually and in a team setting.
• Organized and detail-oriented.
• Strong negotiating skills in a compact clinical team working with aggressive timelines.
• Highly responsive and proactive, a team player.
• Initiative, enthusiasm and a problem-solving approach to new challenges.
• Systematic and efficient coordination skills, including an ability to prioritize.

Reporting to the Clinical Department, the Local Clinical Trial Manager coordinates country-level set-up of the Clinical Trial Protocol for assigned sites, including operational plans, enrollment planning, and monitoring report review. Partnering with the CRO and functions such as manufacturing, logistics, and QA, the Local Clinical Trial Manager maintains GCP and SOP compliance from start-up through close-out.

Leadership Responsibilities

• Serve as primary point of contact at country level for assigned clinical trial sites and manage pro-actively the study progress, leading all activities to ensure that all trials are carried out in accordance with all relevant pharmaceutical regulations (e.g. GCP, applicable SOPs as well as Clinical Trial Protocol), as well as with quality, budget and timing guidelines.
• Review study relevant documents, e.g. Clinical Trial Protocol, Informed Consent Forms, etc. as required in order to deliver quality data and trial documents/records that are compliant with the assigned Clinical Trial Protocol and SOPs.
• Prepare all required operational plans and manuals to operationalize the Clinical Trial Protocol.
• Plan and support the strategic and tactical study enrollment to ensure enrollment targets are met.
• Review Monitoring Reports and support issue resolving with the CRO.
• Develop, maintain and improve processes within the Clinical Department together with other functional departments (e.g. manufacturing, logistics, QA).
• Write and revise GCP relevant SOPs and respective templates and flowcharts for medicinal products.

Position Requirements

• Scientific degree (for example in Chemistry, Biology, Pharmacy or Medicine), with a PhD an advantage.
• Professional experience in clinical research and in the management of (international) clinical trials.
• Experience in clinical monitoring is an asset.
• Ideally a solid background in immunology, hematology or oncology and strong interest in cellular therapies.
• Naturally communicative, able to work independently, pro-actively, goal-oriented and willing to coordinate project teams.

Sitting at the intersection of early phase strategy and global trial operations, the Global Clinical Trial Manager guides study level planning, clinical site selection, and Dose Level Review meetings. Operating across local study teams, site investigators, vendors, and functional service providers, the Global Clinical Trial Manager holds clinical programs to timeline and keeps investigators engaged in each study.

Strategic Responsibilities

• Lead study level planning of the overall clinical operation results.
• Develop early phase clinical operation strategy and contribute to strategic scenario planning in clinical development plan.
• Develop and maintain study timeline and development of clinical protocol and informed consent.
• Contribute to the development and/or review of study-related documentation, including but not limited to monitoring plan, risk management tool, eCRF, manuals, training materials, safety and regulatory documents, and clinical study report, etc.
• Lead clinical study team to identify, evaluate and select clinical sites.
• Handle the day-to-day operations of clinical trial at a global level and resolve issues called out by the local study team.
• Maintain close collaboration with site investigators through regular and ad hoc investigator and site meetings, keeping investigators, often including key thought leaders, engaged to the study.
• Train study team members and/or sites to conduct the study.
• Lead and coordinate Dose Level Review meetings, communicate decisions of the meetings, and operationalize Dose Level Review meeting outcomes.
• Manage vendors and functional service providers (FSP).

Knowledge Skills & Abilities

• Doctorate degree.
• Master's degree and 3 years of clinical experience.
• Bachelor's degree and 5 years of clinical experience.
• Bachelor's Degree or equivalent required (scientific or healthcare discipline preferred).
• 4+ years of experience of clinical research and study management.
• Experience in clinical program management.
• Substantial experience in biotechnology and/or pharmaceutical clinical research with responsibilities for major aspects of strategic planning, organization, implementation, and delivery of clinical programs.

A key member of the project team, the Clinical Trial Manager coordinates the clinical monitoring team, project-specific CRA training, the trial budget, site selection, and site visits. Collaborating across Project Managers, CRAs, and clients, the Clinical Trial Manager ensures each trial stays aligned with SOPs, local regulations, and CFR, ICH, and GCP guidelines.

Ownership Areas

• Collaborate with Project Manager to set targets for clinical monitoring staff and ensure the recording of trial in compliance with project goals.
• Create and implement study-specific clinical monitoring tools and documents.
• Create and oversee the trial budget.
• Identify, enlist, and choose sites, and coordinate site management activities.
• Coordinate and supervise clinical monitoring team.
• Provide Clinical Research Associates with project-specific training and hold regular meetings with them.
• Record and share interactions with clients, and act as their representative.
• Arrange and oversee site visits.
• Gather and examine trial documents.
• Assure compliance with SOPs and local regulations, and CFR, ICH, and GCP guidelines.

Professional Experience

• Bachelor's degree in nursing or life sciences.
• 7+ years of work experience for a pharmaceutical company or related field.
• Proficient understanding of marketing and statistics.
• Understanding of Electronic Data Capture (EDC).
• Proficient with Microsoft Office Word and Excel.
• Outstanding communication skills, both verbal and written.
• Ability to work independently and prioritize duties.