CLINICAL RESEARCH MANAGER JOB DESCRIPTION

A Clinical Research Manager holds that operational center: the person accountable for study conduct from site selection through database lock. This role reports into Clinical Operations or a Head of Clinical Operations and carries direct responsibility for CRO oversight, GCP compliance, and cross-functional coordination across regulatory, data, and medical affairs teams. ICH E6 adherence is not a background requirement here - it is the daily standard.

As the Clinical Research Manager, you ensure that pharma-sponsored clinical trials are initiated, executed, and closed in compliance with FDA regulations, ICH/GCP guidelines, and internal SOPs while staying on time and within approved budgets. Direct accountability spans vendor contracts, site monitoring programs, and the clinical operations staff whose performance determines whether study deliverables reach sponsors on schedule.

Career Impact: Managing multi-site, sponsor-funded trials under ICH/GCP and FDA oversight develops the regulatory and operational depth that advances a CRM toward Director of Clinical Operations roles within pharma and CRO organizations.

Business Impact: Sponsors and investigators depend on this role's monitoring oversight and data reconciliation to keep trial data clean enough for regulatory submission - a study with compromised source data cannot support an NDA.

Growth Opportunity: Hands-on experience with TMF governance, CRO selection, and inspection readiness creates measurable market value for senior roles in global clinical operations or regulatory affairs.

• Lead monitoring and site management activities across assigned trials to ensure ICH/GCP, SOP, and protocol compliance at every active site.
• Manage CRO and vendor relationships, reviewing proposals, negotiating scope of work, and overseeing adherence to service agreements and study timelines.
• Develop and maintain study management plans covering monitoring, TMF oversight, vendor governance, and pharmacy operations.
• Review and approve site visit reports, escalate risk and compliance findings, and drive resolution with documented action plans.
• Coordinate cross-functional deliverables including clinical protocols, CRFs, consent forms, and study reference manuals through to final approval.
• Oversee trial budgets for assigned vendors, review invoices against milestones, and communicate variances to Clinical Operations leadership.
• Guide and mentor junior clinical operations staff, conducting performance reviews and providing individualized development feedback.
• Collect and analyze site-level productivity and delivery metrics to support resource planning and proactive risk identification.

• Bachelor's degree in Life Science, Health Science, or a related field, or equivalent work experience.
• 5 or more years of clinical research experience in pharma-sponsored trials, with at least 2 years in a direct study or site management capacity.
• Working knowledge of FDA regulations, ICH/GCP guidelines, and applicable SOPs governing clinical trial conduct.
• Demonstrated ability to manage CRO and vendor relationships, including contract review and scope-of-work oversight.
• Experience authoring or reviewing monitoring plans, site visit reports, and standard operating procedures.
• Strong CAPA management and risk identification skills applied to audit findings and inspection readiness activities.
• Clear written and verbal communication skills sufficient for sponsor-facing updates, regulatory correspondence, and staff performance documentation.
• Proven ability to manage multiple concurrent studies and prioritize competing deliverables without loss of data integrity.

• Certification through SoCRA (CCRP) or ACRP (CCRA or CCRC), reflecting formal credentialing in clinical research practice.
• Experience conducting or overseeing co-monitoring visits and supporting FDA or EMEA regulatory inspection preparation at investigational sites.
• Background in oncology, rare disease, or IVD clinical research, where protocol complexity and regulatory scrutiny are elevated.
• Familiarity with centralized monitoring methodologies and eTMF governance in a multi-country trial environment.

• Protocol deviation rate per site, tracking how effectively monitoring activities prevent or catch compliance gaps.
• TMF completeness score at interim and final review milestones, reflecting document governance discipline.
• Percentage of site visit reports reviewed and approved within the agreed turnaround window each quarter.
• Budget variance per vendor, measuring accuracy of invoice review and scope-change identification.
• CAPA closure rate within defined timelines, indicating how quickly audit and inspection findings are resolved.
• Typical tools: Clinical trial management systems (commonly Veeva Vault, Medidata Rave); eTMF platforms (commonly Veeva eTMF, Trial Interactive)

• Base Salary Range: $90,000 to $130,000 depending on seniority and CRO or sponsor context.
• Bonus: 8 to 15% annual target, tied to study milestone delivery and compliance outcomes.
• Equity: stock options or RSUs common at biotech sponsors; less typical at CROs.
• Health Benefits: medical, dental, and vision coverage; employer contribution standard.
• PTO: 15 to 20 days annually, plus company holidays and sick leave.
• Common Perks: Remote or hybrid study management roles, conference attendance, GCP training reimbursement, professional certification support.

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

Background screening, including criminal history review and, where applicable, drug testing, is a condition of employment for all positions. All applicants are considered without regard to race, color, religion, sex, national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable federal, state, or local law. Reasonable accommodations are available to qualified individuals with disabilities throughout the application and employment process - requests may be directed to the hiring team. Candidates must hold current authorization to work in the United States; sponsorship eligibility varies by employer.

The Clinical Research Manager owns independent protocol development and multi-site Beta trial oversight for an IVD-focused diagnostics organization, ensuring FDA-compliant study design and GCP-certified team performance across concurrent external and internal clinical sites. Reporting to Clinical Affairs leadership and collaborating with QA/RA cross-functional teams, this role delivers the structured trial infrastructure and regulatory documentation that enables reliable diagnostic product evaluation and advancement.

Key Responsibilities

• Lead development of independent protocols and reports for external Beta trials at clinical sites, and internal sites if necessary.
• Lead the development of contracts, budgets and the necessary IRBs for each project, and develop a network of reliable sites for continuing relationships in Beta trials performance.
• Coordinate planning of resources for multiple concurrent external trials from all product lines to ensure appropriate personnel and equipment/materials for each trial.
• Lead monitoring of active trials including activities related to ensuring protocol compliance, troubleshooting and other remote and on-site support for personnel, interim data collection and coordination with the appropriate technical group, and communication with project team and management as required.
• Represent Clinical Affairs in cross functional teams and work with QA/RA on study design to meet FDA requirements.
• Manage the Clinical Affairs group including all training, evaluations and compliance with code of ethics and policies.
• Ensure that all members of the Clinical Affairs team obtain training and a level of certification in Good Clinical Practices.
• Ensure the team is compliant with all Quality Systems training requirements and obtains a degree of proficiency and cross training on all instrument platforms.
• Serve as a resource to other groups for Good Clinical Practices.

Required Qualifications

• Advanced degree in Life/Health Sciences and/or a minimum of 10 or more years of experience in the clinical laboratory and/or IVD industry or equivalent.
• Project management experience is a plus.
• Experience with writing technical protocols and reports including execution of data manipulation and analysis with software for IVD method evaluation.
• Knowledge and experience with medical device regulations, CLSI guidance documents, product development, design controls, IVD instrumentation, clinical chemistry and laboratory practice sufficient to make informed decisions on protocols and reports.
• Outstanding writing and editing skills.
• Demonstrated self-direction and leadership including experience in managing employees as well as the ability to function as a member of a project team.
• Ability to communicate effectively with members of diverse project teams in data reviews and reports as well as with management as required.

Embedded within the Clinical and Translational Science Program, the Clinical Research Manager supervises a team of 3+ clinical coordinators and oversees the flagship Human Trisome Project cohort study, managing concurrent clinical research collaborations according to established timelines and GCP standards. Working closely with the Clinical Trials Program Manager, administrative staff, and external stakeholders including pharmaceutical representatives and regulatory agents, this role shapes the operational execution and recruitment programs that sustain a longitudinal Down syndrome research portfolio.

Core Functions

• Provide oversight, direction and leadership for clinical research operations.
• Work with the Clinical Trials Manager and/or Executive Director to develop collaborations, set goals, and define priorities for the clinical coordination team.
• Supervise a team of 3+ full-time clinical coordinators, including performance review and management, coaching and mentoring, interviewing and hiring.
• Monitor and actively direct workload of clinical coordinators.
• Provide oversight of Good Clinical Practice (GCP) in all studies.
• Develop program/project goals and communicate goals and outcomes with a variety of stakeholders.
• Participate in tactical and strategic program/project development and planning.
• Develop and implement research recruitment programs to promote diversity and inclusion in study participants.
• Lead and participate in program/project start up and close out functions.
• Liaise and coordinate with a variety of program/project stakeholders including program/project sponsors, regulatory agents, pharmaceutical representatives, and clinic/hospital staff.
• Develop and maintain a variety of reports and communicate and present data to stakeholders.
• Assist with and oversee the day-to-day operations of clinical trials and studies.
• Assist with duties and responsibilities of clinical coordinators when necessary, including performing study visits for Spanish-speaking participants.
• Manage the implementation of cognitive testing batteries, including providing appropriate training to coordinators and performing assessments with Spanish-speaking participants as needed.

Qualifications & Experience

• Bachelor's degree in any field, or a combination of education and related technical/paraprofessional experience substituted on a year for year basis.
• Advanced degree in science or health related field preferred.
• Five or more years of clinical research experience working with vulnerable populations, including children and participants with intellectual/developmental disability.
• Prior supervisory or management experience in a clinical research setting.
• Experience administering and training others to administer cognitive and neuro-psych assessments.
• Knowledge of supervisory techniques, management principles, and organizational leadership.
• Expert knowledge and understanding of federal regulations and Good Clinical Practice (GCP).
• Knowledge of basic human anatomy, physiology, and medical terminology.
• Ability to interpret and master complex research protocol information.
• Experience with electronic data capture systems such as REDCap and Epic.
• Ability to set goals and motivate team members to achieve results.
• Ability to communicate effectively, both in writing and orally.
• Ability to establish and maintain effective working relationships with employees at all levels.
• Outstanding customer service skills and comfort working with individuals with disabilities and their families.
• Demonstrated commitment and leadership ability to advance diversity and inclusion.
• Bilingual, preferably Spanish speaking.

Reporting to clinical research leadership, the Clinical Research Manager leads staffing, performance management, and study feasibility evaluation for an oncology-focused clinical research organization, with direct accountability for disease group strategy development and process improvement across the study portfolio. Partnering with disease site leaders, finance teams, and key stakeholders, this role delivers the operational structure and resource allocation frameworks that enable compliant, efficiently resourced oncology trial conduct.

Primary Duties

• Identify, hire and on-board high quality candidates committed to furthering the mission of the clinical research organization.
• Collaborate with clinical trials office trainer and assigned preceptor/mentor in training of new staff members and staff members who are undergoing re-training.
• Assess for and provide individualized professional development opportunities as appropriate and available for staff members.
• Assess equity and appropriateness of compensation as appropriate.
• Provide performance feedback to staff members on a regular basis that is timely, clear and actionable with documentation of that feedback captured when necessary.
• Evaluate workload allocation for staff members and groups and redistribute, as appropriate.
• Provide back-up support for study management activities when necessary.
• Collaborate with key stakeholders in the development of structure and resource allocations for new programs.
• Attend disease group team meetings on a regular basis.
• Collaborate with disease group leader in defining strategy of disease group development through evaluation of study portfolio, projecting resourcing needs, providing appropriate information/metrics and other support as requested by the disease site leader.
• Communicate organizational information to the disease site leaders and team investigators in a timely manner.
• Evaluate proposed studies to determine feasibility of conduct and ability to adequately resource in collaboration with disease site leader, study team and finance team.
• Conduct ongoing evaluation of processes and procedures for opportunities to improve through efficiency, quality checks or other improvement methods.
• Effectively communicate process improvement opportunities, engage key stakeholders, and solicit feedback.

Skills & Qualifications

• Bachelor's degree and 5 years of relevant experience, including 1 year of personnel management experience.
• Master's degree preferred.
• Clinical research certification (SoCRA, ACRP) preferred.
• Strong understanding of clinical research requirements with regard to staffing, systems and processes.
• Deep knowledge and experience with FDA, ICH GCP and other regulatory guidelines that govern clinical research.
• Oncology clinical research experience preferred.
• Proficiency in Microsoft Office programs including Word, Excel, and PowerPoint.
• Working knowledge of Access, EPIC, and/or Oracle.
• Ability to lead a group, serve as a mentor and/or facilitator, and create a positive work environment.
• Ability to set appropriate priorities and manage time.
• Strong critical thinking skills, problem-solving abilities, organizational skills and multi-tasking capabilities.
• Solution-oriented approach to issues and ability to use tact and diplomacy to maintain effective working relationships.
• Excellent written and verbal communication skills.
• Self-starter with ability to work independently but collaboratively as part of a team.

Sitting at the intersection of clinical operations and vendor governance, the Clinical Project Manager independently manages the full scope of assigned pharma-sponsored clinical trials, ensuring CRO and vendor performance, TMF integrity, and ICH/GCP compliance from site selection through database lock. Operating across cross-functional teams including Clinical Development, Contracts, and Data Management while reporting to the Head of Clinical Operations, this role delivers the study management infrastructure that keeps trials on time, within budget, and audit-ready.

Duties

• Support defined aspects of clinical trials to ensure trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
• Contribute to the development of contracts for assigned vendors, review proposals and make award recommendations.
• Participate in selection of CROs and vendors.
• Manage the assigned CROs/vendors to ensure that project goals are achieved.
• Organize and lead teleconferences with key vendor personnel, facilitate vendor activities and oversee adherence to scope of work and service agreement.
• Participate in developing and finalizing cross-functional deliverables such as clinical study protocols, CRFs, consent forms, study reference manuals, study reports, annual reports and other clinical documents.
• Manage study budgets for assigned vendors.
• Review invoices for assigned vendors, identify and communicate variances for assigned vendors.
• Partner closely with Head of Clinical Operations, Clinical Development and CRO to identify and select clinical trial sites.
• Partner with Contracts department and CRO on the development of site budget, templates and negotiations with sites, until execution.
• Perform oversight and/or co-monitoring visits of clinical sites as required by the needs of project.
• Review and approve monitoring reports and escalate issues and risks to Head of Clinical Operations.
• Ensure that clinical data from a variety of sources is appropriately captured, monitored, source-verified, edit-checked, and reconciled.
• Coordinate and participate in routine and final database lock data listings review.
• Participate in implementation and oversight of study systems e.g, CTMS, TMF, EDC, or IxRS.
• Contribute to creation and implementation of assigned study management plans, (e.g. monitoring, vendor oversight, Pharmacy, TMF oversight, etc.).
• Ensure that supportive study supplies and documents are available (e.g., contracts, IRT, lab kits, non-clinical supply materials).
• Create, maintain, and conduct ongoing quality review of the TMF to ensure files are properly maintained and up to date, archived and stored.
• Reconcile site payments against patient visits to ensure accurate payments.
• Track key study activities using tracking tools and report study progress to Head of Clinical Operations and at clinical team meetings.
• Identify issues and risks, and propose potential resolutions.
• Assist with planning investigator meetings and developing content and/or site training materials.
• Assist with training vendors and team members on study protocol and processes.
• Attend meetings, take and distribute meeting minutes.
• Participate in department process improvement initiative and system implementation.
• Provide training and mentoring to junior clinical operations staff.

Requirements

• BS/BA in Life Science or related discipline.
• 6+ years of relevant industry experience in pharma-sponsored clinical research (at least 3 years of direct study management experience).
• Sponsor experience is preferred.
• CRA/monitoring experience is a plus.
• Effective team player and ability to influence and collaborate with cross functional clinical study teams.
• Strong leadership skills, self-motivated, adaptable to a dynamic environment.
• Effective written and interpersonal communication skills.
• Ability to manage delegated aspects of assigned clinical trials.
• Ability to manage assigned clinical study vendors.
• Strong planning and organizational skills.
• Working knowledge of FDA & ICH/GCP regulations and guidelines.
• Good English language skills are required for non-native speakers.

A key member of the Epidemiology Operations team, the Clinical Research Manager leads day-to-day project management of multiple concurrent client-facing research projects, developing timelines, budgets, and scientific report workflows that deliver on-time outputs to subscribers. Collaborating across investigator teams, finance, and senior epidemiology leadership while reporting to the Director of Epi Operations/Project Management, this role builds the project infrastructure that sustains a real-world data and observational registry research portfolio.

Key Deliverables

• Understand and manage the requirements for each project (including scientific queries, quarterly reports, and safety reports), and effectively coordinate projects for on-time deliverables to subscribers.
• Facilitate communication with clients, provide updates, education, and assure that the clients understand the processes the teams follow to complete projects.
• Develop project timelines, tracking system and budgets.
• Provide leadership to the team by building and motivating team members to meet project goals to adhere to timelines, adhering to responsibilities and project goals/milestones.
• Maintain project documentation, track progress on projects, and work with team and other investigators to overcome barriers.
• Establish and monitor projects in the ERP system.
• Interact on a regular basis with the Finance team, on the approval of time, invoicing and for questions about billing and forecasting of revenue.
• Format, edit, and review scientific reports, obtaining final sign-off as necessary prior to delivery to subscribers.
• Facilitate meetings and project conference calls; plan agenda and lead meetings, ensure that minutes are taken, edited, and distributed.
• Collaborate on and assist with the preparation of abstracts, posters, and manuscripts; and to manage the publication process including development, documentation, and quality control.
• Represent the company or department at client meetings, internal meetings, or other professional meetings (as required).

Experience & Qualifications

• Master's degree in Public Health, Epidemiology, Biostatistics, or related degree with 2+ years of project management experience, or at least 5 years of experience as a project manager for relevant clinical research projects.
• Familiarity with research in real world data, or observational registries a plus.
• Adherences to ethical business and research practices.
• Comfortable with fast-paced environment and able to simultaneously work on several projects.
• Requires a strong working knowledge of MS Office, Word, PowerPoint, Excel, and SharePoint.
• Familiarity with working in Salesforce or FinancialForce a plus.

Sustained GCP compliance across outsourced monitoring operations depends on the Clinical Research Manager, who leads inspection readiness activities, coaches compliance managers, and drives risk-managed solutions in collaboration with Clinical Quality Assurance and functional trial teams. Based within the compliance function and partnering with CRO oversight leads, regulatory inspectors, and third-party vendors, this role ensures that audit findings are resolved, SOPs are current, and clinical trial teams are prepared for FDA and EMEA regulatory inspections.

Accountabilities

• Provide coaching, guidance, and mentorship to compliance managers.
• Support creation of the vision, strategy and objectives for GCP Compliance group and independently develop and execute initiatives and activities to deliver against defined vision and objectives.
• Provide operational oversight of outsourced monitoring activities, including CRO/site oversight visits as a study compliance manager to ensure proactive risk and compliance activities are integrated into planning and execution of assigned clinical trial(s).
• Identify and anticipate quality issue trends and collaborate with functional management to ensure risk-managed solutions are implemented in a timely fashion.
• Provide support and guidance to functional/clinical trial teams in drafting responses to address audit/inspection findings.
• Lead and support inspection readiness activities in close collaboration with Clinical Quality Assurance and ensure clinical trial team members are trained and prepared for regulatory inspections.
• Conduct pre-inspection visits at investigational sites/third party vendors to support inspection readiness activities.
• Provide guidance on regulations, GCP and other guidelines to functional/clinical trial and program teams.
• Maintain or update Standard Operating Procedures (SOPs), Working Practices (WPs) and Policy Documents in the area of compliance.

Knowledge Skills & Abilities

• Bachelor's degree or equivalent qualification in life science/healthcare, Master's degree is preferred.
• Many years of experience in the range clinical/industry/health authority, including several years with focus on quality and compliance (GCP auditor background preferred).
• In-depth knowledge of current regulatory and ICH GCP requirements.
• Strong experience of CAPA management, risk management and audits/regulatory inspections (e.g. FDA, EMEA).
• Experience in contributing to or authoring Standard Operating Procedures (SOPs), Working Practices (WPs) and job aids.
• Experience leading or participating in process improvement initiatives.
• Strong project management and organizational skills.
• Strong interpersonal, problem-solving, negotiation and conflict resolution skills.
• Very good written and verbal communication.
• Effective in establishing and maintaining good collaborations across functions, business units and external partners.
• A growth mindset.

As the Clinical Research Manager, this role leads full-cycle study coordination, regulatory documentation, and subject recruitment within an ophthalmic clinical research setting, maintaining GCP and HIPAA compliance standards across trial operations and patient interactions. The clinical and administrative team relies on this work to ensure data accuracy, equipment integrity, and seamless patient and provider communication that supports compliant ophthalmic trial conduct.

Role Responsibilities

• Manage full cycle study coordination and regulatory documentation.
• Conduct extensive data analysis and interpretation using data analysis programs.
• Provide oversight for the setup, operation, and maintenance of research equipment/instruments.
• Follow established policies, procedures, and objectives, continuous quality improvement objectives, and safety, environmental, and/or infection control standards.
• Recruit subjects for trials and developing tools to improve clinical trial conduct.
• Develop credible relationships with patients and providers.
• Track documents and correspondence - receive, print, scan and sort.
• Ensure documents are complete and accurate, recognizing discrepancies and making corrections.
• Answer incoming phone calls to resolve patient inquiries, follow up as needed.

Education & Experience

• High school diploma or equivalent.
• JCAHPO certification COA level or above or willingness to receive that certification with 6 months of employment.
• BLS Certified, GCP certification.
• Infusion Therapy training preferred.
• 3 years of ophthalmic experience.
• Knowledge of procedures and diagnostics involved in an ophthalmic examination.
• Willingness to participate in continuing education in the ophthalmic and clinical research fields.
• Strict adherence to HIPAA regulations.
• Ability to work independently; planning, organizing, scheduling and completing work within deadlines.
• Multi-task, managing conflicting demands and priorities.
• Demonstrated attention to detail, accuracy and thoroughness.
• Process and procedure oriented.
• Highly organized and efficient.
• Communicate clearly and professionally, both in oral and written correspondence.
• Demonstrated consistency and dependability in attendance, quantity and quality of work.
• Interacts professionally with managers, peers, patients and health-care providers.
• Use of discretion regarding current, ongoing, or new projects in research and patient confidentiality and protection etc.

Clinical Research Manager leads operational management of Global Medical Affairs research programs including Company Sponsored Studies, Investigator Initiated Research, and Collaborative Research studies across assigned therapeutic areas, ensuring accurate tracking of performance metrics and compliant cross-functional review of submissions. Success in the position means that budget reviews, protocol approvals, and disclosure obligations are executed on schedule, and that internal and external stakeholders across pharmaceutical and CRO environments receive timely, transparent reporting on evidence generation outputs.

Areas of Ownership

• Manage operational aspects of assigned Global Medical Affairs (GMA) related research studies and trials for programs including Medical Affairs Company Sponsored Studies (MACS), the Takeda Investigator Initiated Research (IIR) programs, and Takeda Collaborative Research program (Collaborative Research) studies for assigned therapeutic areas and product programs.
• Oversee the tracking of Medical Affairs studies/programs/projects by working closely with internal/external stakeholders and communication of key outputs, operational/performance metrics, and accomplishments related to Global Medical Affairs (GMAO) Evidence Generation.
• Manage the appropriate disclosure of study related information.
• Facilitate receipt, processing, and internal cross-functional review of internal/external programs/projects submissions.
• Review budgets, protocols and informed consent documents.
• Lead required cross-functional review meetings to review, approve, and track programs/projects.

Professional Experience

• Bachelor's degree required, preferably in a health sciences related field with 3-5 years of research related experience and pharmaceutical industry experience.
• Proven track record of leadership, project management and demonstrated ability to coach individuals.
• Communicate and interact thoughtfully, transparently, and appropriately with a variety of clients both internal and external.
• Experience overseeing work of and mentoring other individuals with a variety of scientific and non-scientific backgrounds and training - preferred.
• Research experience (health sciences related), Pharmaceutical Industry including CRO - preferred.

The Clinical Research Manager produces end-to-end clinical study management for sponsor and CRO clients, owning project plans, site selection, IRB protocol drafting, and Clinical Trial Agreement finalization while serving as the primary client contact for assigned trial responsibilities. Reporting to the Clinical Research Program Director and collaborating with cross-functional teams spanning Project Management, Clinical Operations, and Regulatory Affairs, this role advances study execution from kick-off through close-out in compliance with ICH/GCP guidelines and applicable regulatory requirements.

Day-to-Day Responsibilities

• Lead cross-functional teams with Project Management, Clinical Operations, and Regulatory Affairs, while understanding and managing client expectations.
• Proactively manage project-level operational aspects of Clinical Trial Team (CTT) including management of trial timeline, budget, resources, and clients.
• Strategically plan and coordinate all phases of a clinical study from development to execution, analysis and interpretation.
• Independently develop project plans, manage study timelines and communicate progress with cross-functional stakeholders.
• Develop and maintain successful working relationships with study sites and cross-functional team members, defining and implementing project scope, deliverables, risk mitigation strategies, and issue resolution.
• Provide efficient updates on trial progress to the Clinical Research Program Director and/or Senior Director of Clinical Research Operations (DCO), with respect to client selection, project plans, trial budget and timeline management, quality standards, and risk mitigation.
• Identify clinical sites that are qualified to conduct clinical trials as required by clients.
• Draft clinical protocols and protocols for the Institutional Review Board (IRB) in accordance to regulatory guidelines.
• Lead sponsor study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of the trial's electronic filing system, site selection, and finalization of the site and client Clinical Trial Agreements and budgets.
• Ensure all ethical practices and legal protocols are followed and that all paperwork is filled out completely and accurately.
• Maintain standards for the data collection and procedures during the clinical trial and make sure all team members involved are kept informed.
• Work proactively with the Clinical Trial Team (CTT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines, and regulatory requirements.
• Serve as key client contact for assigned project responsibilities, establishing working relationships with client project teams which result in client satisfaction, operational excellence, and increase potential for repeat business.
• Monitor the quality of deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution, and quality control across the team.

Background & Experience

• Bachelors' degree in life science, biology, or a related field.
• Must be an ACRP Certified Professional and/or a Certified Clinical Research Professional or CCRP (SOCRA).
• Project coordination and/or project management experience.
• Clinical Research Coordinator (CRC) experience.
• Two or more years of clinical project management experience as a sponsor or CRO company is preferred.
• Self-starter with an analytical mindset.
• Strong attention to detail.
• Exceptional interpersonal skills.
• Outstanding written and verbal communication.
• Excellent communication, planning and organizational skills.
• Read, write and speak fluent English; excellent verbal and written communication skills.
• Willingness to learn and gain knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and data management methods.

Embedded within the Clinical Operations Unit of a contract research organization, the Clinical Research Manager coordinates and oversees country and site management activities during study conduct, holding accountability for CRA training, monitoring plan development, and financial and contractual compliance across all assigned project phases. Working closely with project teams, clinical operations staff, and site personnel while reporting through the CRO organizational structure, this role oversees the site-level delivery performance and resource allocation decisions that determine whether study deliverables are met on time and in compliance with ICH/GCP, SOPs, and protocol requirements.

Scope of Work

• Oversee all aspects of monitoring and site management activities ensuring compliance with ICH/GCP guidelines, SOPs and protocol requirements.
• Lead, manage and guide CRAs being responsible for training and quality oversight of site management activities while proactively identifying potential operational issues and ensuring study deliverables.
• Development of Study Monitor plans, Monitor and Site Training plans, verification initiatives, coordinating Study Investigator Meetings and reviewing site and country Study Reports.
• Ensure study processes, procedures and expectations correspond to the practicality of conducting the trial from study feasibility through to close out.
• Serve as initial point of contact for the monitoring team and support them with investigative site personnel liaison.
• Implement monitoring/recruitment plans and support also the design of CRF completion guidelines.
• Perform co-monitoring visits as part of the monitoring team quality oversight.
• Review and approve site visit reports (PSV, SIV, MV and COV) with agreed and act as first point of contact for issue escalation ensuring the proper resolution and action plan definition and follow up.
• May provide Line management of assigned staff within Clinical Operations.
• Participate in resource planning and staff allocation discussions to ensure that project teams are appropriately resourced during all phases of a project.
• Ensure assigned staff achieve expected quality compliance standards by providing appropriate oversight.
• Collect and analyze delivery, productivity and performance metrics.
• Provide pro-active guidance and direction to assigned staff around site selection, site management, site monitoring, site close out and customer management to assist in service delivery and professional development.

Minimum Qualifications

• Minimum of 5 years of experience in clinical research with at least 1 year as CRM at CRO or Sponsor, 3 years as Senior CRA/Lead CRA and/or at least 2 years as CRA Manager or equivalent role.
• Recent experience of direct line managing CRAs is an asset.
• Fundamental knowledge of Clinical Research, and expertise in all phases of a Clinical trials, additionally to CTMS/eTMF expertise with a Centralised Monitoring experience preferable.
• Previous experience in delivery trainings with excellent presentation and mentoring/training skills.
• Ability to work independently as well as in a team matrix organization and multiple projects.
• Confident, articulate and professional speaking abilities in fluent English.
• Empathic listener and persuasive speaker.
• Writing factual and creative.
• Ability to work independently as well as in a team matrix organization and liaise successfully with clinical project teams and other relevant departments.
• Demonstrate ability to identify, analyze and solve problems.

Reporting to hospital research leadership, the Clinical Research Manager I develops and oversees multiple clinical research projects simultaneously, including data management systems, investigator training programs, and grant and protocol writing in collaboration with hospital investigators and statisticians. Partnering with a matrix team of scientific staff, data management personnel, and sponsored education program stakeholders, this role produces the study infrastructure and training curriculum that enables GCP-compliant clinical research operations across an academic medical center.

Strategic Responsibilities

• Lead and manage the work of multiple clinical research projects.
• Serve as Clinical Research Study / Trial Manager for one or more large, clinical studies.
• Collaborate and consult with investigators and their staff on the design, development, and conduct of clinical research studies and on clinical research best practices.
• Work with study investigators and statisticians to plan analyses, clean and verify data and facilitate preparation of datasets for analyses.
• Collaborate directly with Hospital investigators and CRP scientific staff on developing and writing grants and study protocols.
• Develop curriculum, conduct lectures, and direct courses as part of sponsored educational efforts to train clinical investigators and study staff in clinical research regulations and best practices.
• Lead design and development of data management and data monitoring tools and procedures and supervise data management staff and activities in compliance with GCP and program standards.
• Lead and collaborate with matrix team to design and develop study databases and related products and procedures.
• Manage Staff's Performance Reviews.
• Ensure work is performed in conformance with established hospital, program, federal, and state policies and procedures.

Technical Qualifications

• Knowledge of theories, principles, and concepts typically acquired through completion of a Bachelor's degree in STEM or Psychology.
• Master's degree preferred.
• 6 years' relevant work experience or Master's Degree and 4 years' relevant experience.
• Analytical skills to gather and interpret data in which the information or problems are moderately complex to complex.
• Well-developed communication skills in order to provide critical information to patients, effectively deal with conflicting views or issues, and the ability to mediate fair solutions.
• Advanced writing skills.