Clinical Study Manager Job Description

A Clinical Study Manager runs a drug trial so it finishes on plan. In pharmaceutical and biotech sponsors, the position sits inside Clinical Operations below a Clinical Program Lead, holding operational accountability for one or more Phase I to IV studies while CROs, central labs and investigator sites carry out much of the fieldwork under its oversight. The hard part is delegation without control. Every decision must hold up against ICH GCP and FDA expectations, and the Trial Master File has to be inspection ready long before a Health Authority asks for it.

As the Clinical Study Manager, you are accountable for delivering assigned drug trials to agreed budget, timeline and quality so clean data reaches database lock on schedule. You will lead a cross-functional study execution team from start-up to close-out, guided by a Clinical Program Lead and supported by Regulatory Affairs.

Career Impact: Running Phase I to IV studies under ICH GCP gives you sponsor-side ownership of CRO contracts and study budgets, experience that clinical operations hiring panels screen for above monitoring alone.

Business Impact: Accurate enrollment forecasts and a timely database lock keep IND and NDA submissions on their planned dates for the therapy area you support.

Growth Opportunity: Line management of junior study staff prepares you for Senior Clinical Study Manager and Associate Director roles overseeing larger trial portfolios.

• Lead the cross-functional study execution team from start-up through close-out within agreed time, cost and quality parameters.
• Direct CRO, central lab and ancillary vendor performance against contracted scope, deliverables and budget.
• Establish study timelines, enrollment projections and risk mitigation plans, escalating critical issues to program leadership.
• Review site monitoring reports and monitoring visit findings to confirm protocol, SOP and ICH GCP adherence.
• Validate Trial Master File completeness so the study stays inspection ready for sponsor and regulatory audits.
• Coordinate study document development, including protocols, informed consent forms, CRFs and pharmacy and lab manuals.
• Own study budgets, invoice reconciliation and change orders, providing accrual and forecast input to finance.
• Mentor junior study staff through delegated responsibilities, quarterly check-ins and year-end performance reviews.

• Bachelor's degree in life sciences, healthcare or a related scientific discipline or equivalent work experience.
• 3 or more years of clinical research or clinical operations experience, with sponsor, biotech or CRO exposure.
• Documented training in and application of ICH GCP guidelines and FDA regulations governing clinical trials.
• Demonstrated project management capability covering study planning, timeline tracking, risk assessment and contingency planning.
• Experience managing clinical trial budgets, including contract negotiation, forecasting and vendor or site payments.
• Experience overseeing CROs, central laboratories and other clinical study vendors against contracted deliverables.
• Working knowledge of clinical study documents, including protocols, informed consent forms, CRFs and TMF requirements.
• Strong written and verbal communication skills, with the ability to negotiate with investigators, site staff and partners.

• Master's degree, PhD or equivalent advanced qualification in a life science field alongside project management experience.
• Direct experience preparing for and supporting regulatory authority inspections or sponsor and QA audits of clinical studies.
• Line management experience, including performance reviews and development planning for clinical study staff.
• Contribution to writing Investigator's Brochures or clinical sections of IND, DSUR or NDA regulatory submissions.

• Enrollment rate versus plan, showing how well site selection and recruitment forecasts hold.
• Milestone adherence of study milestones met on schedule), tracking timeline control from start-up to close-out.
• Budget variance actual versus forecast spend), reflecting control over vendor costs and change orders.
• TMF completeness score, indicating inspection readiness of study documentation.
• Days from last patient visit to database lock, measuring data review and reconciliation speed.
• Critical audit or inspection findings, reflecting protocol and GCP compliance oversight.

• Base Salary Range: $120,000 to $165,000 per year depending on seniority and trial complexity
• Bonus: Annual performance bonus, typically 10% to 15% of base salary
• Equity: Stock options or RSUs common at biotech sponsors, less so at large pharma
• Health Benefits: Medical, dental and vision coverage with employer-paid premiums for employees
• PTO: 15 to 25 days annually plus paid company holidays
• Common Perks: 401(k) match, hybrid work options, and funding for ACRP or SoCRA certification

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 depend on successful completion of a background check, which may include drug screening and verification of prior 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 under federal, state or local law. Reasonable accommodations are available upon request throughout the hiring process.

The Clinical Study Manager leads assigned clinical trials from start-up through close-out, directing a cross-functional study execution team to deliver TMF, vendor and CRO oversight within quality, time and cost parameters. Reporting to the Clinical Program Lead within Clinical Operations, the manager partners with Regulatory Affairs and Clinical Supply Chain to keep trial delivery on schedule and advance the drug development pipeline.

Key Responsibilities

• Lead all aspects of assigned clinical trials, applying strong knowledge of clinical operations methodologies, organizational, project management and leadership capabilities, and use project management skills to ensure adherence to a standardized, consistent approach that drives Clinical Operations performance.
• Manage clinical trial projects by leading and delegating to a cross-functional study execution team (CST) from start-up through close-out under the guidance of the Clinical Program Lead, ensuring planning, execution and delivery within quality, time and cost parameters.
• Manage people through performance oversight and development, quarterly check-ins, year-end performance appraisals and ongoing constructive feedback for direct reports.
• Mentor junior team members by delegating responsibilities, including aspects of project management, and overseeing and supporting development plans.
• Ensure the TMF is created, maintained, monitored and closed out on time, and that site monitoring reports are accurate, thorough, regularly reviewed and aligned with metrics.
• Manage Central Lab and ancillary vendor selection, set-up, conduct and close-out, and oversee or delegate CRO oversight as the primary point of contact to ensure committed resources, deliverables, performance goals and contracted terms including budget are met.
• Oversee clinical trial timelines, act as escalation point to the Clinical Program Lead and Program Management Lead, and keep senior Clin Ops staff, DCT and line function heads informed of risks by putting mitigation plans in place, monitoring risk metrics and communicating risks.
• Work with Regulatory Affairs to establish submission timeframes and ensure accurate, comprehensive Health Authority submission documents.
• Coordinate timely exchange of information and materials (e.g., subject enrollment, site selection/feasibility, data collection) with other functions, and with Clinical Supply Chain on drug forecasting and supply to sites.
• Support timely database lock by ensuring monitoring plans are in place and participating in data review and reconciliation.
• Oversee invoice reconciliation, scoping and change orders, and participate in clinical trial scenario planning by estimating time and cost.
• Ensure trials are operationally feasible with awareness of the external landscape including KOL activity, lead timely trial activation, and proactively identify, negotiate and broker solutions to study issues.

Required Qualifications

• Bachelor’s degree or higher in a scientific or healthcare discipline preferred.
• Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required.
• 3-5 years of progressive experience in clinical research or clinical operations within the biotech, pharmaceutical sector or CRO industry.
• Experience developing trial plans including site monitoring, pharmacy and lab manuals, risk mitigation strategies, trial budgets and site selection/feasibility as required.
• Management experience of CROs, Vendors and Consultants preferred.
• Regulatory authority inspection experience a plus.
• Therapeutic or medical knowledge preferred.
• Ability to adhere to the clinical trial budgeting process and provide input to finance on budget accruals and forecasts.
• Strong written and verbal communication skills.
• Ability to collaborate effectively with the study team, cross functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.

Embedded within a clinical research unit running early-phase studies, the Clinical Study Manager I delivers start-up, clinic conduct and close-out activities, from protocol review and TMF upkeep to supervising dosing and randomization visits. Working closely with Project Managers, sponsors and QA teams, the Clinical Study Manager I keeps every study compliant with protocol, SOP and applicable regulations so sponsors receive accurate data on time.

Core Functions

• Review assigned protocols and related documentation (ICF, IB) for accuracy, feasibility, timing and resources as part of clinical research project planning and preparation.
• Prepare, maintain, review and update the Trial Master File (TMF) for the study.
• Participate in creating and reviewing timelines and start-up meetings (Investigator Meeting/SIV, Sponsor discussions or other related meetings).
• Lead and coordinate start-up activities, including clinic logistics planning, clinic activity schedules, team training, and preparation, review or finalization of source documents, time and events tables, study materials, CRFs, laboratory workbooks, staff requirements and schedules.
• Establish or maintain, with responsible teams, safety assessment requirements, QC and monitoring plans, pharmacy/dispensing requirements, study supplies/equipment, meal plans and other applicable elements, and confirm all regulatory and contractual documentation is present before study start.
• Coordinate and monitor screening activities, clinic room set-up, subject chart review and source preparation before clinic activities begin.
• Lead clinic activities by supervising visits (admission, dosing and randomization, discharge, follow-up), providing on-call support, ensuring volunteer eligibility before randomization and overseeing or performing drug administration as delegated.
• Monitor, with responsible teams, that all study activities follow protocol, SOP and applicable regulations, and review and manage clinic updates, AE/SAE reporting, study logs and trackers, QC and Monitor findings.
• Coordinate resolution of QC, monitor, CRF and other internal or external findings.
• Review or oversee close-out of study documentation, deviation reporting, CRF completion and sign-off, study reports, finalization of study and subject logs, and other close-out activities (return of study supplies, IRB reports, archiving).
• Monitor subject compliance throughout the trial, address day-to-day subject or study issues and escalate as appropriate.
• Prepare for and participate in sponsor, monitor and QA audits, and provide accurate, timely project status updates to Project Managers and the sponsor.
• Collaborate within and between teams on process improvement, SOP creation or revision, internal and external meetings and other company initiatives.

Qualifications & Experience

• University degree such as R.N or Bachelor of Science degree.
• Clinical Research certification is an asset.
• Minimum of 3 years’ experience in clinical research, preferably with previous Clinical Study Manager experience.
• Strong knowledge of regulations, ICH GCP, privacy and applicable guidelines.
• Knowledge of SOP writing.
• Proficiency in computer software programs (e.g., Word, Excel, PowerPoint).
• Proven strong assessment, problem solving, planning and evaluation skills.
• Ability to anticipate problems and provide solutions in a timely manner.
• Proven strong organization and time management.
• Proven ability to coordinate complex or multiple clinical research projects with competing deadlines.
• Proven ability to provide clear and focused leadership.
• Strong interpersonal and communication skills with a team focus.

Reporting into the clinical affairs function, the Clinical Study Manager owns post market medical device studies, handling budgets, Ethics Committee submissions and risk-based monitoring. Partnering with data management, statisticians and CROs, the Clinical Study Manager keeps studies audit ready and generates reliable clinical evidence for surgical products.

Primary Duties

• Manage and execute clinical research activities for company sponsored studies and collaborative research, including post market clinical studies in EU.
• Manage clinical studies including budget, analysis of potential patient recruitment, preparation of study documents (protocols, CRFs, informed consents, clinical trial agreements) and Ethics Committee submissions through to successful outcome.
• Work with data management and statisticians as needed for assigned projects.
• Ensure high levels of data entry compliance and integrity.
• Maintain study documentation (e.g., correspondence, CRFs, deviations, budget information).
• Plan and manage project timelines to ensure clinical studies are conducted on time, and proactively anticipate and communicate concerns, issues or delays.
• Prepare project status updates and PowerPoint presentations for internal stakeholders on assigned projects.
• Ensure compliance with corporate (e.g., SOPs) and regulatory requirements (e.g., GCP and US and OUS guidelines) and audit readiness to relevant regulatory and legal standards.
• Manage Contract Research Organizations (CROs) or independent clinical service providers.
• Perform monitoring and source data verification based on a risk-based approach.
• Participate in meetings and reporting, and adhere to company policies.
• Track Investigator Initiated Trials projects under the research grant program.

Skills & Qualifications

• Graduate qualification in Life Sciences, medicine or medical sciences.
• Work experience in the medical device industry and/or clinical affairs/research function is advantageous.
• Experience reviewing clinical data sets to evaluate data quality and address issues.
• Experience publishing clinical research (own or in clinical industry capacity) is an advantage.
• Monitoring experience is preferred but not essential.
• Awareness of applicable regional medical device regulations and guidelines including GCP, ISO-14155, MEDDEV, MDR and data protection rules.
• Strong numerical and literary analytical skills with the ability to assess data and literature quickly.
• Ability to manage a minimum of two clinical research projects across multiple surgical disciplines.
• Excellent communication and interpersonal skills with strong influencing abilities.
• Ability to work independently and across teams while keeping open communication with key stakeholders.
• English language required, with a second European language (Dutch, French, German) preferred.
• Comfortable in a hospital/surgical environment.

Sitting at the intersection of clinical research and health system innovation, the Clinical Study Manager shapes clinical validation studies for innovative solutions, coordinating protocol design, site training and patient enrollment to time and budget. Operating across matrixed analytic teams, key physicians and Enterprise partners, the Clinical Study Manager turns study outcomes into manuscripts and adoption strategies that guide solution activation within the health system.

Duties

• Consult with team members or other enterprise partners to evaluate clinically innovative solutions and build buy-in with key Enterprise or partner stakeholders.
• Plan and lead delivery of clinical validation studies to time, budget, scientific and governance requirements with matrixed partners and stakeholders across the Enterprise.
• Coordinate study design/protocol, clinical/patient workflow, clinical site training, and patient engagement, enrollment and recruitment.
• Build relationships with key internal and external stakeholders, including key Enterprise partners, to gain buy-in for the test and learn program and individual portfolio solutions.
• Drive milestone-based outcome reporting with the matrixed analytic team, lead creation and finalization of each deliverable, and extract study insights to develop adoption and engagement strategies for the solution in the health system.
• Work with key physicians to develop project design and analytics and build broad support for the solution, including presentations to clinical leadership or other stakeholders.
• Advance dissemination of study outcomes through preparation and review of manuscripts (co-authorship) for publication and other internal or external presentations.
• Engage internal and external customers to maintain alignment with program goals and objectives and provide clear guidance on study objectives, execution and downstream solution activation within the health system.

Requirements

• Bachelor's degree in general science, life/health related science or related disciplines.
• Master's degree in general science, life/health related science or related disciplines.
• 5 years of work experience, or 3 years post graduate degree, with some exposure to innovation or healthcare related fields.
• 3 years in payer, hospital system or care delivery industry.
• 3 years of influencing change in complex organizational systems or 3 years around the research setting, preferably clinical research.
• Ability to solve complex conceptual and operational problems with strong quantitative and analytical skills.
• Basic project management skills.
• Demonstrated influencing and teamwork skills.
• Strong emotional intelligence with a servant leadership mindset.
• Commitment to self-development and the development of others.

A key member of the Clinical Study Team, the Clinical Study Manager leads the execution of assigned clinical studies, supervising CROs, investigational sites and monitoring activities under ICH GCP. Collaborating across Procurement, Outsourcing and fellow Clinical Study Managers, the Clinical Study Manager keeps contracted work within agreed quality, timelines and costs to support reliable study results.

Functions

• Coordinate preparation of study documents (including Protocol Outlines, Protocols, Informed Consent Forms, Diaries, Case Record Forms, Reports), ensure timely delivery, review and approval of documents generated by external parties, and contribute input, reviews and quality checks.
• Supervise monitoring activities, including contributing to plans, reviewing reports and follow-up letters and conducting co-monitoring visits, ensuring full adherence to ICH GCP, the Declaration of Helsinki and relevant standards and regulations.
• Support other Clinical Study Managers in execution activities (document review, co-monitoring, planning/budget review, back-up when needed).
• Participate in the RFP and CRO selection process, including contributing to RFP documents, reviewing proposals, attending bid defense meetings and scoring proposals.
• Track progress of activities contracted to providers and investigators to ensure completion within defined quality, timelines and costs, and review budgets, invoices and agreements with Procurement and Outsourcing teams, ensuring creation of out-of-scope logs and Change Orders.
• Support the Clinical Team in revising or preparing SOPs, WKIs and document templates, and maintain up-to-date knowledge of ICH GCP and relevant regulations.

Experience & Qualifications

• Bachelor’s, Master’s degree or PhD in Life Sciences.
• Substantial experience leading clinical studies and clinical trial monitoring in a pharmaceutical, biotech company or CRO.
• Previous experience managing Real-World Evidence studies and epidemiological studies is an advantage.
• Sound project management skills.
• Good knowledge of EDC systems (e.g., InForm, RAVE, TrialMaster) and electronic Trial Master File (e.g., Veeva, Medidata, IQVIA).
• Good knowledge of MS Office Suite and capacity to learn other IT tools.
• Strong interpersonal skills and ability to collaborate within teams.
• Fluent in written and verbal English, with knowledge of other languages an advantage.

Timely, compliant delivery of international clinical trials depends on the Clinical Study Manager, who builds site readiness, CRO oversight and study timelines for the region outside the US. Serving as liaison between clients and the internal team, the Clinical Study Manager works with clinical, marketing and operations management to keep programs aligned with corporate and R&D objectives.

Accountabilities

• Act as a customer advocate throughout the project lifecycle and serve as liaison between clients and the internal team to proactively communicate project information and updates.
• Understand and support global project goals including site recruitment, patient recruitment, marketing and public relations, as appropriate.
• Implement approved clinical study protocols and operational plans consistent with strategic corporate and R&D objectives, and assume primary accountability for their progress and for compliance of assigned projects with applicable regulations, guidelines and corporate policies.
• Coordinate with clinical, marketing and operations management to identify study goals and scope, and manage the overall project scope and timelines.
• Initiate and train sites to the study protocol and ensure proper site adherence to clinical research regulations.
• Manage resources and timelines for study start-up and implementation, including CRO/investigator agreements, central IRBs and contractual agreements, and support oversight of CROs and other study vendors.
• Plan and manage all materials for study execution, including distribution of documents, forms, supplies, equipment and investigational device.
• Ensure document standardization through model documents, templates and peer review, and ensure appropriate development of all CRO documents, including informed consent forms, case report forms, instructions, site selection materials, investigator updates and other project-specific documents.
• Ensure maintenance of project files and project-specific tracking systems according to applicable regulations, guidelines and corporate policy (e.g., GCPs and company SOPs).
• Ensure operational and regulatory integrity of assigned studies and participate in EMA or other regulatory authority inspections as needed.
• Develop and maintain detailed timelines and resource projections for all programs, provide routine status reports, and prepare internal and external memos, reports, documents and correspondence.
• Ensure internal project team members are trained appropriately for proper study conduct.
• Manage tasks outside the in-life component of studies, including database development, statistical analysis and report writing, and prepare and review clinical data for analysis while managing consultant relationships for data collection and analysis.
• Attend off-site meetings and conferences as needed.

Technical Qualifications

• Bachelor’s degree in the life sciences or a related field.
• Documentation of GCP training.
• 5+ years of experience in clinical research, including 1+ year in clinical project management.
• 3+ years of experience qualifying and managing external vendors (e.g., CRO, Call Center, Central labs).
• Experience leading project operational teams through start-up, study conduct, data management and report writing/review, including writing, reviewing and editing protocols and clinical study reports.
• Experience dealing with decision makers such as physicians, Ethics Committees and Health Authorities, plus international study experience, GDPR implementation and sample management system set-up experience.
• Good knowledge of Good Clinical Practices and all applicable EU, national and regional regulations governing clinical research.
• Working knowledge of the Medical Device or In-Vitro Diagnostic submission process, with knowledge of the Oncology landscape a plus.
• Ability to communicate frequently and accurately with employees, customers and vendors in person, by telephone or by email.
• Ability to exercise judgment on problems of varying complexity, with excellent problem-solving, interpersonal, organization and communication skills.
• Ability to work independently and manage multiple deadlines and timelines while maintaining team focus.
• A can-do attitude with a strong desire to take ownership of many different projects and to work in a fast-paced environment.
• Uphold company mission and values through accountability, innovation, integrity, quality and teamwork, and support and comply with the company’s Quality Management System policies and procedures.
• Authorization to work in the job location without sponsorship and demonstrated ability to perform the Essential Duties with or without accommodation.

As the Non-Clinical Study Manager, this role owns outsourced preclinical safety studies at CROs worldwide, handling sourcing, SOWs, contracts and scientific review of protocols and reports. The project team relies on this work, alongside procurement, legal and preclinical safety experts, to move R&D projects from entry into development up to and beyond NDA submission.

Activities

• Work with internal and external cross-functional teams to manage all non-GLP and GLP outsourced preclinical safety studies (general, reproductive and genetic toxicology, safety pharmacology, phototoxicity, juvenile toxicology) within timelines, budget and quality deliverables.
• Serve as key contact between the Project Team and CROs, handling CRO sourcing, SOW, quotes, invoice management, assistance schedule maintenance, approved AEDs, POs, legal contracts (Master Service Agreements/Confidentiality Agreements), CRO performance and scientific monitoring.
• Monitor study progress and scientific quality, and collaborate with GLP Site Quality Operations and Animal Welfare on study or site audits as required.
• Review and finalize nonclinical study protocols, amendments and reports to meet project timelines, expectations and deliverables.
• Engage internal preclinical safety experts and advisors (safety pharmacologist, pathologist, genetic or reproductive toxicologist, biomarker expert) to maximize scientific evaluation quality and resolve issues as required.
• Facilitate regular communication between project team members, CROs and planning partners.

Position Requirements

• Bachelor’s degree in a scientific field with 10+ years, a Master’s degree with 7+ years, or a PhD with 5+ years of experience in toxicology and/or safety pharmacology (as study director, outsourcing manager or operations manager).
• Good understanding of the broad landscape of CROs and partnerships involved in conducting preclinical studies.
• Familiar with quality regulations (GLP policies), animal welfare and preclinical testing requirements.
• Good knowledge of pharmacokinetics, statistics or related fields with a broader understanding of in vivo biological systems is a plus.
• Knowledge in study and/or project management.
• High degree of self-organization, flexibility, attention to detail, agility and a proactive and reactive attitude.
• Ease in collaborating transversally with internal groups (project team members, procurement, scientific advisors, global planning) and CROs (key account contacts, study directors).
• Team player in a fast-paced environment who takes initiative to identify, analyze and resolve issues and sustains high performance amid constant change.
• Excellent communication and presentation skills.

Associate Director, Clinical Study Manager leads complex rare disease Phase I-II trials, directing a cross-functional Study Team and overseeing CROs, vendors, labs and budgets under ICH/GCP. Success in the position means partnering with the Medical Director on protocol design, delivering trials on schedule and strengthening Clinical Operations infrastructure, standards and processes.

Operational Focus

• Plan, oversee, implement and conduct complex rare disease Phase I-II early-phase clinical trials with key functional areas, external vendors and advisors.
• Contribute to protocol development and study design with the Medical Director and lead protocol feasibility, site feasibility and site selection.
• Lead development of the clinical study plan, including critical path activities, enrollment projections, interdependencies and milestones, and ensure accurate tracking and reporting of study metrics and timelines.
• Identify, lead and manage a cross-functional Study Team for the study duration, resolve issues and disseminate information to team members effectively and on time.
• Oversee performance and management of CROs, vendors, labs and consultants involved in day-to-day study management.
• Oversee development of clinical study documents, including informed consent, protocol amendments, laboratory and pharmacy manuals, eCRF, monitoring and safety plans, study manuals, project plans, vendor oversight plans, recruitment and retention plans, safety review committee charters, Investigator Brochure and Clinical Study Reports.
• Manage program and study budgets, contract negotiation, payments and study spend forecasting, and provide monthly, quarterly and yearly updates.
• Ensure trial adherence to ICH/GCP, Federal and local regulations and company SOPs, including set-up and maintenance of the Clinical TMF.
• Assess potential study risks, propose mitigation plans, resolve issues and manage escalation as appropriate.
• Ensure quality clinical data review and data integrity, and participate in and respond to QA or regulatory authority inspection audits as needed.
• Lead development of Clinical Operations infrastructure, functions, standards, processes and IT systems (e.g., SOP development, training) in compliance with global regulatory standards.

Knowledge Skills & Abilities

• Bachelor’s degree in health sciences or related field, or equivalent.
• 10+ years of experience in clinical research, including at least 7 years in clinical study management and CRO and vendor oversight.
• Extensive and comprehensive knowledge of GCP, Federal Regulations and International Regulations (ICH).
• Strong computer literacy and skills.
• Excellent organizational, communication, interpersonal and decision-making skills.
• Ability to problem solve and use clear judgment regarding regulatory requirements, external interactions, timelines and complex clinical programs.
• Proven ability to build, manage and develop high performing teams, with excellent delegation and conflict resolution skills.
• Ability to communicate with co-workers at all levels and work independently and on teams.
• Demonstrates innovation, drive, energy and enthusiasm to deliver program objectives.
• Fluent in English (oral and written).

The Clinical Study Manager oversees within-country planning and delivery of Phase I-IV clinical trials, leading local study teams to meet recruitment targets, budgets and audit quality. Reporting to line management, the Clinical Study Manager links the central study team with local medical and regulatory affairs so studies stay compliant with ICH GCP across all therapy areas.

Key Deliverables

• Ensure the Brand Heart is brought to life and consistently activated across all touch points to build long term brand equity.
• Lead the local study team of within-country clinical operations members, cross-functional experts (medical, regulatory, supply logistics, finance, legal), vendor staff and external site staff, providing matrix leadership and project management within the countries.
• Serve as operational point-of-contact between the central study team and within-country study team, collaborating with local medical and regulatory affairs on requirements and with local and above-country teams on study feasibility and site selection.
• Deliver assigned studies within countries to time, budget and quality expectations per the clinical development plan, protocol, local regulations, IND/GCP/ICH guidelines and company SOPs and POLs.
• Forecast and achieve critical within-country timelines, meet recruitment targets, patient recruitment cycle times, data and audit quality, and provide troubleshooting and problem resolution for the study team.
• Maintain accuracy of study systems, including trial master file completeness, and report study delivery progress to the study team and key stakeholders.
• Identify and resolve or escalate risks and issues that may impact study delivery.
• Provide feedback on study members' performance, capabilities and competencies to line management, and review and approve monitoring visit reports as required.
• Estimate, track and deliver against the local budget for studies in scope.
• Advise on contract development with sites, CROs and vendors and participate in budget and contract negotiations as needed.

Professional Experience

• Bachelor’s degree or equivalent in any general science, e.g., life science, medicine, clinical research, pharmacy.
• Master of Science, PhD or equivalent coupled with previous project management experience.
• Minimum of 3 years of clinical research experience within the company or externally, with broad experience in clinical development or the pharmaceutical or health-related field.
• Deep knowledge of human research regulations in the countries, IND/GCP/ICH guidelines and company SOP/POL/guidelines.
• Strong project management skills, comfortable projecting, managing and reporting budget information with business and financial acumen.
• Ability to develop scenarios and effective contingency plans.
• Knowledge or ability to acquire expertise in multiple systems and tools related to clinical studies.

Embedded within a clinical team running global trials for a cardiovascular diagnostic system, the Clinical Study Manager develops study plans, IRB submissions, site qualification and monitoring programs with full GCP compliance. Working closely with study sites, vendors and investigators, the Clinical Study Manager manages budgets and data cleaning to deliver top line results that help physicians treat patients with cardiovascular disease.

Areas of Ownership

• Plan, initiate and execute clinical studies with operational excellence, including IRB submissions, site and investigator qualification, site initiation, monitoring and close-out in compliance with GCP and applicable federal regulations.
• Manage budgets, timelines and resources for clinical studies and implement standards and processes to ensure study quality.
• Train and manage interactions with the study team, study sites and vendors.
• Lead day-to-day study operations to ensure completion per established goals in compliance with GCP/ICH guidelines and regulatory requirements.
• Provide accurate, up-to-date study information and regular progress updates.
• Lead development of study plans and system set-up, and ensure operational excellence of the protocol, CRF, CSR and other key deliverables.
• Implement systems, standards and processes to ensure quality at investigative sites, vendors and data.
• Lead preparation of vendor requirements, project scope and vendor selection, and manage interactions with vendor study teams.
• Oversee clinical aspects of timely data cleaning, data analysis and top line results, and participate in data reviews and statistical analysis plan reviews.
• Ensure effective investigator and site monitor training and coordinate operational and therapeutic area training for internal and external team members.

Education & Experience

• BA/BS degree with at least 7 years of clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 5 years of clinical trial experience.
• Strong knowledge of ICH/GCP guidelines and regulatory requirements.
• Strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring.
• Proven project management skills and study leadership ability.
• Computer ability and administrative skills.
• Excellent interpersonal, written and verbal communication skills.
• Fluent in English.

Reporting to clinical leadership, the Senior Clinical Study Manager oversees highly complex studies from start-up through reporting, arranging regulatory and ethics approvals and line managing CSMs and CSAs under GCP. Partnering with Data Sciences, Supplies, Quality, CROs and sites, the Senior Clinical Study Manager introduces operational innovations that sharpen team ways of working and support business strategy.

Role Responsibilities

• Establish smooth, efficient cooperation within the multi-disciplinary project team of Clinical Study Researchers, Clinical Study Assistants (CSAs), Data Sciences, Supplies, Quality and Science.
• Drive innovations within the team, proactively seeking new implementations and changing course when necessary.
• Bring new insights to the company with a pioneering mindset.
• Ensure highly complex studies are set up and conducted in line with GCP.
• Arrange regulatory and ethics submissions and approvals.
• Select, collaborate with and monitor activities of clinical partners (CROs, sites).
• Provide progress reporting on resources, budgets and timelines.
• Contribute to business strategy and apply it to projects.
• Align daily with team members and mentor CSAs and other CSMs.
• Line manage other CSMs or CSAs.

Background & Experience

• Master and/or PhD in life science or related scientific discipline.
• 7+ years of experience in (international) clinical research.
• Line management experience.
• Thorough knowledge of legislation and ICH-GCP guidelines.
• Strong project management and passionate leadership skills.
• Ability to solve complex challenges with unique agile approaches, with problem solving and critical thinking capabilities.
• Excellent communication skills in English and solid influencing skills to interact with internal and external stakeholders.

Sitting at the intersection of clinical affairs and medical device evidence generation, the Clinical Study Manager advances pre and post-market studies, from literature appraisal and protocol writing to IRB/EC submissions and contract negotiation. Operating across biostatistics, marketing and key opinion leaders in academic and community settings, the Clinical Study Manager produces clinical study reports and publications that close evidence gaps for current products.

Job Functions

• Lead pre and post-market clinical research activities in medical devices, focusing on post-market evidence generation studies.
• Collaborate with internal stakeholders and KOLs to develop and review study concepts, protocols and study outlines and drive identified initiatives.
• Conduct literature searches to stay abreast of scientific knowledge, identify evidence gaps for current and future studies and shape the overall program.
• Plan and execute clinical studies, including investigator selection, analysis of potential patient recruitment, creation of study documents (protocols, CRFs, informed consents, clinical trial agreements) and IRB/EC submissions through to successful outcome.
• Independently conduct clinical studies on schedule and within budget while ensuring high quality and compliance.
• Liaise with external vendors and sites to negotiate contracts and budgets.
• Participate in data analysis, interpretation and synthesis with biostatistician support to develop clinical study reports and support scientific publications, including peer-reviewed manuscripts with external KOLs.
• Critically appraise scientific literature and write clinical summaries to support research efforts, clinical strategies and clinical investigational protocols.
• Review and revise Clinical Operations SOPs to support Clinical Affairs Leadership in continuous process improvement initiatives.
• Collaborate with commercial groups (e.g., marketing) to understand market trends and support business goals through Clinical Affairs activities.
• Develop strong relationships with KOLs in academic and community based settings.

Required Qualifications

• Previous experience implementing, supporting and managing pre and/or post-market industry sponsored device trials, including detailed review of study data and/or monitoring.
• Experience conducting literature searches, reviews and appraisal of scientific data is preferred.
• Experience in protocol development and/or writing clinical sections for regulatory submissions for studies or commercially available products.
• Knowledge of the pulmonary space or anatomy, and/or lung cancer is preferred.
• Knowledge of clinical and outcomes research study design is necessary.
• Knowledge of Good Clinical Practice ICH/GCP, 21 CFR Part 11 and international regulations.
• Basic understanding of statistics, statistical methods and design of experiment is preferred.
• Ability to manage or support multiple projects or studies.
• Ability to interact with physicians in academic and community settings and other professionals inside and outside the company, including commercial representatives.
• Strong communication, presentation and interpersonal skills with a high level of attention to detail, accuracy and organization.
• Ability to work effectively on cross-functional teams.
• Self-starter attitude with the ability to learn quickly and self-educate on different surgical specialties as applicable.
• Consistent dedication and strong work ethic to meet aggressive timelines or multiple projects when necessary.
• Comfortable in a hospital environment with experience working with nurses and surgeons.

A key member of the clinical operations group, the Clinical Study Manager oversees assigned clinical studies from startup to closeout, managing CROs, trial agreements, budgets and study monitoring under GCP/ICH. Collaborating across CMC, Finance, Legal, Regulatory and QA, the Clinical Study Manager keeps milestones on track and supports regulatory filings such as INDs and NDAs for the product portfolio.

What You'll Do

• Collaborate with operational project team members and stakeholders from CMC, Finance, Legal and Regulatory Affairs on clinical vendor KPIs, ensuring compliance with study specifications (timelines, deliverables, budgets) and applicable SOPs.
• Execute study management with thorough understanding of drug development, GCP/ICH standards and health authorities (FDA/EMEA), applying this knowledge from startup through conduct to closeout.
• Participate in study center selection, pre-study qualification, initiation and closeout.
• Coordinate and conduct study monitoring with CRAs to ensure compliance, data quality, proper documentation and study completion.
• Oversee plans and preparation of Essential Documents (e.g., Patient Informed Consent Forms, 1572s).
• Identify, manage and supervise clinical CRO and consultant activities.
• Negotiate clinical trial agreements and budgets, and manage the budget and vendor site payments.
• Participate in developing study documents such as protocols, SOPs, work instruction documents, informed consent forms and CRFs.
• Participate in preparing and writing Investigator's Brochures and clinical sections of regulatory documents such as INDs, DSURs and NDAs (and international equivalents).
• Participate in and support publications based on the clinical program.
• Communicate with cross-functional colleagues (Regulatory, QA, CMC, Finance) to keep all stakeholders informed and aligned on clinical activities.
• Recommend and implement innovative process ideas that impact clinical trial management and cost efficiency.

Qualifications & Experience

• Proven ability to plan, conduct and manage clinical operations from early through late phase trials, with global trial experience preferred.
• Demonstrated ability to manage CROs, central laboratories and other clinical study vendors.
• Working knowledge of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety/pharmacovigilance and regulatory affairs.
• Ability to contribute to the development of clinical protocols, project-related documents, clinical study reports and summary documents for regulatory submissions.
• Effective planning and project management skills, including risk assessment, contingency planning and ability to prioritize.
• Demonstrated ability to handle a high volume of highly complex tasks within a given timeline.
• Effective communication and interpersonal skills to articulate plans, results and analysis to project teams and senior management, listen, seek clarification and respond to inquiries or complaints.
• Ability to build strong relationships with external parties such as key opinion leaders and clinical investigators.
• Excellent organizational and problem-solving skills with the capacity to organize assignments and work within deadlines.