CLINICAL PROJECT MANAGER JOB DESCRIPTION

Review Clinical Project Manager job descriptions across pharma, biotech, and CRO environments to benchmark responsibilities, qualifications, and industry expectations.

Clinical Project Manager Job Description Template

1. About the Role

Protocol timelines slip. That is the everyday consequence when nobody owns both the operational rhythm of a multi-site study and the regulatory accountability that ICH-GCP demands. A Clinical Project Manager stops that from happening. Working across sponsor organizations, contract research organizations, and central laboratories, this role holds end accountability for trial conduct from site activation through TMF inspection readiness. The scope spans Phase I through Phase IV studies, and the stakeholders range from IRB coordinators to biostats teams to executive leadership tracking pipeline milestones.

2. Position Summary

Clinical Project Managers in pharmaceutical and CRO environments are accountable for the on-time, on-budget delivery of clinical trials that meet GCP, FDA, and ICH regulatory standards, while managing cross-functional teams, external vendor relationships, and study-level P&L. Portfolio scope typically covers multiple concurrent studies, with the role answering to a Clinical Program Manager or VP of Clinical Operations and serving as the primary operational point of contact for CRO partners and investigational sites.

3. Why Join Us

Career Impact: Deep experience managing Phase I–IV trials under ICH-GCP gives Clinical Project Managers a credential set that sponsors, CROs, and biotech firms all compete to hire, positioning the right candidate for Clinical Program Manager and Director-level roles within a defined path.

Business Impact: When study timelines hold and TMF files pass inspection without findings, the sponsor's regulatory submission stays on schedule — a direct connection between this role's daily decisions and a drug's path to patients.

Growth Opportunity: Exposure to multi-regional trial execution, vendor contract negotiation, and risk management across therapeutic areas builds a profile that opens doors to global program leadership and cross-functional director roles.

4. Key Responsibilities

  • Own trial delivery from study startup through clinical study report, maintaining compliance with ICH E6 R2 and applicable FDA regulations.
  • Lead cross-functional project teams spanning data management, biostatistics, medical writing, regulatory affairs, and clinical operations to hit study milestones.
  • Develop and manage study-level budgets including CRO pass-through reconciliation, invoice approval, and monthly accrual reporting to finance.
  • Select, oversee, and hold accountable external vendors including CROs, central laboratories, and IVRS providers against contracted scope and timelines.
  • Identify trial risks and implement contingency plans, escalating unresolved issues to the Clinical Program Manager with documented resolution paths.
  • Maintain the Trial Master File in continuous inspection-ready condition and support regulatory agency audits as required.
  • Draft and review essential study documents including protocols, informed consent forms, monitoring plans, and clinical study reports.
  • Coordinate investigational site activation, ongoing site management, and protocol deviation tracking across multi-site studies.

5. Required Qualifications

  • Bachelor's degree in life sciences, pharmacy, nursing, medicine, or a related health science field, or equivalent work experience.
  • Five or more years of clinical trial operations experience, with at least two years of direct project management responsibility in a sponsor or CRO environment.
  • Working knowledge of ICH-GCP, FDA regulations, and IRB and ethics committee submission processes.
  • Demonstrated ability to manage study-level budgets, forecast resource requirements, and oversee vendor contracts and pass-through costs.
  • Experience authoring or reviewing core trial documents including protocols, ICFs, monitoring plans, and clinical study reports.
  • Proven track record managing cross-functional teams in a matrix environment without direct line authority over all contributors.
  • Strong written and verbal communication skills with the ability to negotiate with and manage expectations of diverse clinical stakeholders.
  • Ability to identify critical path risks, build contingency plans, and escalate decisions with supporting documentation.

6. Preferred Qualifications

  • Formal project management certification such as PMP or equivalent, applied in a clinical research context.
  • Experience managing multi-site international studies across EMEA or global regions, including country-level regulatory submissions.
  • Prior exposure to real-world evidence study designs such as retrospective analyses, registry studies, or survey-based protocols.
  • Background in a specific therapeutic area such as metabolic health, oncology, or ophthalmic drug development providing domain depth valued by sponsors.

7. Success Metrics & Environment

  • Study milestone adherence rate, measuring on-time completion of site activation, enrollment, and database lock against approved timelines.
  • TMF completeness score at each scheduled inspection readiness review, reflecting document control discipline.
  • Budget variance percentage per study, tracking forecast accuracy against actual CRO and pass-through spend.
  • Protocol deviation rate per 100 patient visits, indicating site oversight and monitoring effectiveness.
  • Vendor deliverable on-time rate across CROs and central labs under active management.
  • Typical tools: Clinical trial management systems (commonly Veeva CTMS or Medidata); project planning software (commonly MS Project or similar portfolio tools).

8. Compensation & Benefits (US Market Benchmark)

  • Base Salary Range: $95,000 to $135,000 depending on seniority and CRO or sponsor setting.
  • Bonus: 8% to 15% annual target, tied to study delivery and portfolio performance.
  • Equity: stock options or RSUs common at biotech and mid-stage pharma sponsors.
  • Health Benefits: medical, dental, and vision coverage; employer contribution typical.
  • PTO: 15 to 20 days annually, plus company holidays and sick leave.
  • Common Perks: Remote or hybrid flexibility, conference attendance, professional development stipend.


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

9. EEO & Legal

Successful completion of a background check, and where applicable a drug screening, is a condition of employment for all positions. All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, disability, age, veteran status, or any other characteristic protected under applicable federal, state, or local law. Candidates requiring a reasonable accommodation during the application or interview process may request one at any time. Candidates must be authorized to work in the United States.

Clinical Project Manager Job Description Examples

1. Clinical Project Manager (Multi-Site Clinical Trial Management)

The Clinical Project Manager owns delivery of multiple complex clinical and laboratory services projects, ensuring compliance with GCP standards and regulatory expectations while coordinating cross-functional teams across CRO and sponsor environments. Reporting to clinical leadership, this role shapes study quality by managing TMF inspection readiness, vendor oversight, and continuous process improvement initiatives spanning research, biostats, data management, and finance.


Key Responsibilities

  • Manages multiple complex clinical and laboratory services projects for existing and new clinical studies.
  • Applies project management and leadership skills to deliver projects on time, within budget, and with high customer satisfaction.
  • Manages and coordinates cross-functional project teams to support milestones and address study issues while ensuring compliance with clinical objectives and regulatory expectations.
  • Aids in the development of the Quality System supporting GCP and other compliance tools.
  • Aids in the development of study tools such as study management plans, Investigator Brochure maintenance, and training materials.
  • Aids in the oversight of clinical research organizations and third parties involved in clinical studies.
  • Identifies gaps, potential bottlenecks, and delays, and proposes options to close gaps and get projects back on track.
  • Develop proactive contingency plans to mitigate clinical risk and manage issues and resolutions.
  • Identify quality issues through review of site communications, monitoring visit reports, data management information, and audit findings to implement corrective action plans.
  • Provide input for the development of RFPs for CRO selection, including comparison of vendor proposals.
  • Review and approve vendor invoices in collaboration with the accounting team to ensure invoicing accuracy.
  • Ensure the TMF is maintained and in a state of inspection readiness.
  • Lead and participate in continuous process improvement and standardization initiatives, establishing best practices and assessing key performance metrics.
  • Serve as liaison between functional areas including research, medical writing, clinical operations, regulatory, medical affairs, biostats, data management, and finance.


Required Qualifications

  • Bachelor's Degree in life sciences, medicine, pharmacy, nursing, or a related field.
  • Formal project management certification a plus.
  • Minimum 4 years of experience in a CRO, sponsor, or clinical project management capacity.
  • Strong working knowledge of the pharmaceutical industry.
  • Knowledge of clinical trials management, bio-sample management, and process flow.
  • Knowledge of IRB, ethics committee, and regulatory oversight processes.
  • Knowledge of ICH, GCP, and FDA regulations and guidelines for medical devices and pharmaceutical or biologic agents.
  • Experience with writing SOPs and policy documents.
  • Experience with maintenance of ClinicalTrials.gov.
  • Proficiency with word processing, spreadsheet, database, and email software including Outlook, Excel, and Word.
  • Strong negotiation, meeting facilitation, written, and verbal communication skills.
  • Strong leadership, project management, and interpersonal skills with ability to work in a team environment.
  • Ability to multitask, prioritize multiple ongoing projects, and coordinate day-to-day activities under time pressure.
  • Ability to apply specialized knowledge when interfacing with third-party vendors and internal cross-functional teams.
  • Attention to detail, results-oriented approach, and commitment to precision and data quality.
  • Forward-thinking, positive, self-motivated, and proactive with strong resourcefulness and initiative.
  • Ability to effectively function and execute in a fast-paced, dynamic environment.

2. Clinical Project Manager (Real-World Evidence & Clinical Supply)

Embedded within the clinical and divisional teams, the Clinical Project Manager delivers multiple moderately complex evidence generation studies leveraging real-world data to support regulatory, marketing, and decision-making requirements. Working closely with the Clinical Program Manager and external vendor partners, this role builds study protocols, manages trial budgets, and executes project plans across non-patient-enrolling study designs including retrospective, survey, and meta-analysis methods.


Core Functions

  • Manage planning and communication with cross-functional teams to ensure proper execution and conduct of the trial.
  • Work with multiple stakeholders to pull work deliverables into focus.
  • Leverage commercial datasets and existing data using non-patient study tools and designs such as survey, retrospective, and meta-analysis methods.
  • Execute highly visible projects and define, manage, and own project scope.
  • Create trial budgets and work with cross-functional managers to maintain cost within budget.
  • Develop trial communication management plans for project teams and stakeholders.
  • Gain input, develop, and execute study protocols, study reports, and study project plans.
  • Work closely with data management, statisticians, and medical writers to ensure deliverables are met.
  • Demonstrate thorough knowledge of clinical research conduct, laws, regulations, and standards, and coach others in their appropriate application.
  • Assist in the development of in-house operations SOPs, guidelines, and systems.
  • Maintain up-to-date knowledge of published literature in relevant therapeutic areas.
  • Support the Quality Policy by building quality into all aspects of work and maintaining compliance with all quality requirements.


Qualifications & Experience

  • Bachelor's degree required or experience as a medical healthcare professional.
  • Minimum 6 years of experience in clinical trials.
  • Working knowledge of GCP, ICH guidelines, and FDA regulations.
  • Experience in protocol and report development with familiarity with various data collection tools.
  • Experience developing evidence leveraging real-world data preferred.
  • Proficiency in resource planning and financial management including clinical trial budgeting preferred.
  • Previous experience within a sponsor organization or clinical research organization preferred.
  • Effective process and project management skills.
  • Demonstrated problem-solving abilities in overseeing clinical studies.

3. Clinical Project Manager (International Clinical Trials Operations)

Reporting to the business project manager, the Clinical Project Manager leads all operational and strategic aspects of clinical trial conduct for the Clinical Research Unit Team, ensuring flawless execution in compliance with ICH Good Clinical Practice, internal SOPs, and applicable laws. Partnering with investigators, ethics committees, CROs, and central laboratories, this role contributes measurable improvements to budget control, vendor coordination, and Trial Master File integrity across multi-site international studies.


Primary Duties

  • Provide critical reviews and operational input for development of clinical substantiation and protocol outline during study setup.
  • Provide realistic timelines and state practical, valid operational models.
  • Provide strategic and tactical guidance in risk management taking into account business interests.
  • Identify project and clinical trial risks, create contingency and mitigation plans, and implement solutions.
  • Assess investigational sites and staff suitability to conduct the protocol and secure stakeholder agreement with assessment outcomes.
  • Select, manage, and coordinate external vendors such as CROs and central laboratories.
  • Manage operational aspects of the clinical study and ensure delivery according to ICH GCP and quality standards.
  • Prepare and review essential trial documents, maintain Trial Master Files, and manage regulatory and ethics committee submission processes.
  • Manage budget and report to the relevant business project manager.
  • Coordinate investigational product preparation, logistics, and biological sample management throughout the trial.
  • Contribute to the strategy of the Clinical Project Management Group by identifying areas for efficiency improvement.


Skills & Qualifications

  • University degree or equivalent in a related scientific field.
  • At least 5 to 8 years of clinical project management experience in the food, pharma, or CRO industry or in an academic setting.
  • Proven experience leading and coordinating activities of cross-functional operational teams.
  • Experience working with clinical sites to execute protocols.
  • Experience managing multi-site, international clinical studies including vendor and site selection, oversight, budget, and contracts management.
  • Experience in risk management.
  • Excellent communication skills with ability to convince, negotiate with, and manage expectations of key clinical trial stakeholders.
  • Strong problem-solving attitude and a creative mindset.
  • Fluent in English; other European languages considered an asset.

4. Clinical Project Manager (CRO Client-Facing Study Delivery)

Sitting at the intersection of client relationship management and clinical trial execution, the Clinical Project Manager leads project deliverables, P&L accountability, and quality standards across assigned studies within a CRO or pharmaceutical organization. Operating across cross-functional study teams and external client stakeholders, this role develops client satisfaction at the study level while ensuring on-time, on-budget completion in compliance with GCP and ICH guidelines across all trial phases.

Duties
  • Independently responsible for all project leader tasks and deliverables according to SOPs on assigned projects.
  • Perform initial and ongoing risk management, identify potential project risks, and implement contingency plans.
  • Manage and ensure first-time quality on project deliverables and establish quality standards that drive team commitment.
  • Develop and manage the client relationship at a study level and ensure high client satisfaction through consistent communication.
  • Understand and own the project P&L including revenue recognition, forecasting, resource management, and pass-through management.
  • Manage the cross-functional project team and enable all stakeholders to achieve successful study completion.

Experience & Qualifications
  • An established background as a clinical project manager with strong understanding of GCP ICH guidelines and experience delivering clinical projects on time and within budget.
  • Extensive professional understanding of the clinical trial process covering all phases.
  • Previous experience from a CRO, biotech, or pharmaceutical organization.
  • Proven track record of developing client relationships internally and externally at program level.
  • Global exposure preferred; regional EMEA or EU experience considered.
  • Proven substantial leadership experience.
  • Ability to travel regionally or globally as required for site visits and meetings.

5. Clinical Project Manager (Clinical Supply Chain)

A key member of the clinical supply chain function, the Clinical Project Manager oversees protocol-level supply planning and execution for Phase I through IV clinical trials, ensuring investigational drug availability to sites and depots on time and within budget. Collaborating across clinical study teams, regulatory affairs, and logistics partners, this role authors study medication labeling, forecasts bulk drug requirements, and manages risk and contingency planning for investigational product supply.

Functions
  • Forecast, plan, schedule, coordinate, and execute to ensure timely availability of investigational drug supplies and related services to clinical sites and depots.
  • Provide input to clinical study teams to influence protocol design for efficient utilization of supply chain resources.
  • Translate clinical study design into packaging design.
  • Author the study medication and labeling section of the clinical protocol.
  • Develop protocol-specific labeling compliant with applicable global regulations.
  • Identify, develop, communicate, and track project timelines, activities, logistics, and milestones.
  • Handle protocol-specific clinical supplies scenario analysis, risk management, and contingency planning.
  • Forecast protocol-specific bulk drug product requirements including comparator agents, ancillary supplies, and commodities.

Education & Experience
  • Bachelor's Degree in a relevant field.
  • 2 or more years of experience in the pharma industry.
  • Solid understanding of clinical development and global supply chain requirements.
  • Solid understanding of compliance requirements in a regulated environment.
  • Competency in the application of standard business requirements including SOPs and global regulations.
  • Experience in drug discovery, drug development, clinical operations, supply chain, or quality assurance.
  • Project management skills with solid problem-solving and time management abilities.
  • Excellent written and verbal communication skills.
  • Strong attention to detail and highly organized work approach.
  • Strong interpersonal skills.

6. Clinical Project Manager (National and International SAKK Trials)

Timely trial completion and budget adherence depend on the Clinical Project Manager, who leads the preparation, conduct, and conclusion of national and international studies in line with ICH-GCP guidelines for a clinical research organization. Based within the project team and serving as the primary contact for investigators, participating companies, and external service providers, this role manages the Trial Master File, monitors schedules, and implements corrective measures to keep study execution on track.

Accountabilities
  • Prepare, conduct, and conclude national and international trials in line with ICH-GCP guidelines.
  • Monitor schedules and budgets allocated to trials, report progress, and implement corrective measures.
  • Maintain the Trial Master File.
  • Manage and coordinate the project team and external service providers.
  • Serve as point of contact during projects for investigators, participating companies, and other project partners.

Requirements
  • Degree in science with a BSc or MSc in Biology, Biomedical Sciences, Biochemistry, or Pharmacy, or a paramedic qualification.
  • Proven experience in project management and coordinating clinical trials.
  • Two to four years of experience planning and conducting clinical trials in line with ICH-GCP; Phase I trial experience is an advantage.
  • Up-to-date knowledge of the regulatory environment in Switzerland.
  • Precise, conscientious, and target-driven approach with a strong sense of responsibility and quality.
  • Assertive with good organizational skills, outstanding teamwork and communication skills, resilience, and a proactive approach.
  • Service-oriented mindset.
  • Very good knowledge of German and English; knowledge of French or Italian is an advantage.

7. Clinical Project Manager (Ophthalmic Clinical Trials)

As the Clinical Project Manager, this role drives ophthalmic clinical trials forward on behalf of sponsors by managing cross-functional project teams, maintaining weekly budget and progress reviews, and ensuring all study milestones, regulatory requirements, and SOPs are met. The clinical development team relies on this work to coordinate stats, data management, safety, manufacturing, regulatory, and vendor groups within a matrix environment while preparing high-quality financial and project reports for senior management.

Project Responsibilities
  • Manage cross-functional project teams to deliver high-quality clinical trials in compliance with all regulations and SOPs.
  • Work with functional areas on initiating, planning, executing, controlling, closing, and resourcing clinical trial projects.
  • Coordinate interdepartmental and intradepartmental groups including stats, data management, safety, manufacturing, regulatory, and vendors in a matrix environment.
  • Review protocols, source documents, and CRFs, and track them to completion.
  • Create and maintain project timelines and use them to track and manage project progress.
  • Create project plans including roles and responsibility tables and communication plans.
  • Provide weekly project budget and progress reviews for each study.
  • Review study metrics for performance and quality with the team and management.
  • Prepare high-quality financial and project reports for management on program status and issues.
  • Ensure review of the clinical electronic Trial Master File for completeness.
  • Manage and coordinate all vendors involved in clinical trials including central labs, IVRS, and reading centers.
  • Represent the organization at professional meetings or seminars as needed.
  • Adhere to clinical values of prioritizing kindness, operational excellence, cultivating joy, and scientific rigor.

Minimum Qualifications
  • Bachelor's degree in life science with at least 5 years of clinical trial experience; additional experience may be considered in lieu of education.
  • Minimum 1 year of clinical project management experience.
  • Ophthalmology experience preferred.
  • Understanding of multi-center drug and device trials.
  • Demonstrated expertise in applicable regulatory requirements and GCP.
  • Experience with Veeva TMF and CTMS systems.
  • Proficiency with Excel and PowerPoint and vendor management.
  • Highly effective organizational and communication skills.
  • Ability to establish and maintain effective professional relationships with co-workers, managers, and clients.
  • Ability to plan, identify risks, anticipate issues, and respond strategically and operationally while balancing short-term and long-term objectives.
  • Demonstrated leadership skills with ability to multitask and solve problems proactively.
Multi-lingual communication is a plus.

8. Clinical Project Manager (Medical Device Clinical Research)

Clinical Project Manager oversees the full planning and execution of medical device clinical studies, developing study protocols, informed consent forms, case report forms, and regulatory submission reports while ensuring compliance with FDA regulations, ISO standards, and GCP. The work directly supports on-time, on-budget delivery of clinical evidence across investigational sites, external vendors, and cross-functional teams including key opinion leaders, consultants, and site monitoring personnel.

Day-to-Day Responsibilities
  • Oversee the planning and execution of clinical studies including timeline development to ensure deliverables are completed on time and within budget.
  • Develop clinical study protocols, informed consent forms, case report forms, and other essential study documents.
  • Develop clinical study reports for submission to regulatory authorities.
  • Develop and track the clinical study budget including invoice review, approval, and monthly accruals.
  • Oversee and review deliverables produced by study team members to ensure quality and compliance.
  • Manage external vendors to ensure deliverables are completed on time, within budget, and within scope of work.
  • Ensure studies comply with applicable policies, standards, FDA regulations, ISO standards, GCP, and other regulations.
  • Serve on cross-functional project teams as a clinical subject matter expert.
  • Develop and implement standardized processes and operating procedures for conducting clinical research.
  • Supervise department personnel as needed.
  • Create and maintain clinical study documents as part of the Trial Master File.
  • Interact with investigational sites, vendors, key opinion leaders, and consultants.
  • Conduct on-site clinical monitoring activities as needed.
  • Lead and actively participate in cross-functional team meetings.

Background & Experience
  • BA or BS in a health science field required; MA or MS preferred, or equivalent combination of training and experience.
  • 5 or more years of experience in clinical research.
  • 3 or more years of experience managing clinical research studies.
  • 3 or more years of experience managing medical device studies preferred.
  • Strong working knowledge of GCP, FDA and ISO regulations, and current industry practices related to clinical study conduct.
  • Therapeutic knowledge and experience with peripheral vascular devices for PAD, ESKD, or oncology preferred.
  • Previous experience managing or mentoring personnel preferred.
  • Previous site monitoring or CRA experience preferred.
  • Strong computer skills and proficiency with Microsoft Office Suite applications.
  • Excellent oral and written communication skills.
  • Strong interpersonal and organizational skills.
  • Ability to work independently, manage multiple projects and personnel in a fast-paced environment, and effectively navigate obstacles.
  • Ability to effectively prioritize tasks and ensure project milestones are met or exceeded.

9. Clinical Project Manager (Transcatheter Mitral and Tricuspid Therapies)

The Clinical Project Manager leads planning and execution of tactical clinical research projects and study conduct activities within the transcatheter mitral and tricuspid therapies space, holding accountability for on-scope, compliant completion of assigned deliverables. Reporting to senior clinical project managers, the team depends on this work to manage query resolution, documentation reviews, competent authority audits, and cross-functional team coordination in line with Good Documentation Practices and applicable regulations.


Role Responsibilities

  • Plan clinical research projects and study conduct activities with accountability for successful completion within scope of project deliverables.
  • Provide direction and guidance to smaller project teams to execute tactical clinical research projects and initiatives.
  • Work with cross-functional teams including clinical data management and field teams on query management, data reviews, and resolution.
  • Identify and evaluate process improvements and course correction opportunities.
  • Conduct in-house and site reviews of associated documentation and lead internal and competent authority audits to ensure compliance with Good Documentation Practices, internal SOPs, and applicable regulations.
  • Partner with senior clinical project managers in leading regular team meetings.


Knowledge Skills & Abilities

  • Proven successful project management skills.
  • Proven expertise in Microsoft Office Suite including advanced Excel.
  • Extensive knowledge of clinical research processes and systems.
  • Extensive knowledge within own area of the organization while contributing to new concepts, techniques, and standards.
  • Excellent documentation, communication, and interpersonal relationship skills including negotiating and relationship management with ability to drive achievement of objectives.
  • Ability to interact professionally with all organizational levels.
  • Ability to represent leadership on project sections interfacing with project managers and teams.
  • Strict attention to detail.
  • Adhere to all applicable rules and requirements including health, safety, and environmental protocols.
  • Ability to manage competing priorities in a fast-paced environment.

10. Clinical Project Manager (Metabolic Health and Drug Development)

Embedded within an international drug development unit focused on metabolic health and chronic inflammation, the Clinical Project Manager oversees trial delivery from startup through clinical study report, maintaining compliance with ICH E6 R2 and EU regulations across all study phases. Working closely with clinical service providers, investigational sites, and cross-functional teams, this role monitors budgets defined per study contract and generates regular status updates for internal management throughout conduct.


Scope of Work

  • Manage operational delivery of a clinical trial from start to clinical study report within set timelines, within budget, and with the highest achievable quality.
  • Ensure day-to-day oversight and management of start-up, conduct, and close-out phases of clinical projects according to applicable rules and regulations including ICH E6 R2 and EU regulation.
  • Monitor progress of clinical trials against set timelines, predefined budgets, and quality standards.
  • Ensure development of and contribution to all documents needed in clinical research including study synopsis, protocol, project plan, monitoring plan, ICF, data management plan, and clinical study report.
  • Monitor and manage the study budget as defined per study contract.
  • Generate study status updates for internal management on a regular basis during trial conduct.


Professional Experience

  • Masters or bachelor's degree in pharma, life sciences, or a health-related field.
  • At least 5 to 10 years of experience in clinical trial operations, preferably in international or global drug development.
  • Good knowledge of ICH-GCP.
  • Experience in conducting trials in metabolic health or chronic inflammation is a strong plus.
  • Experience in global drug development.
  • Experience in clinical operations in food trials is considered a plus.
  • Experience in a biotech environment is a plus.
  • Strong project management skills including proactive planning and organization with experience managing cross-functional teams in clinical development.
  • Skilled in working with Microsoft Office programs including Word, Excel, and PowerPoint.
  • Good communication and interpersonal skills with experience managing sites, clinical service providers, and vendors.
  • Maintains high ethical standards including commitment to organizational values and policies.
  • Aware of and sensitive to cultural differences.
  • Fluent in English in both writing and speaking.
  • Existing right to work in Europe required.

11. Clinical Project Manager (Clinical Operations & CRO Management)

Reporting to the line manager, the Clinical Project Manager coordinates the planning, execution, and CRO and vendor management of clinical trial projects to ensure compliance with protocols and overall clinical objectives across healthcare and life science settings. Partnering with finance, CRO partners, and cross-functional study leads, this role advances study timelines, negotiates clinical trial agreements, and contributes to the development of standard operating procedures supporting clinical operations.


Performance Expectations

  • Plan, execute, and coordinate clinical trial projects to ensure compliance with protocols and overall clinical objectives.
  • Manage study timelines and budgets and negotiate clinical trial agreements.
  • Select and manage CROs and vendors for outsourced clinical trials.
  • Participate in preparation and management of research budgets and provide input to finance on budget accruals and forecasts.
  • Monitor the quality of CRO and vendor deliverables.
  • Assist in the development and maintenance of standard operating procedures for clinical operations.
  • Participate in the development of study protocols including guidelines for administration and data collection procedures.
  • Complete clinical trial-related tasks as assigned by line manager.


Education & Experience

  • Bachelor's degree or above in healthcare, life science, or equivalent fields.
  • At least 6 years of experience in all operational aspects of planning and executing clinical studies with at least 2 years of project management experience.
  • Good communication skills with strong negotiation and presentation skills.
  • Proficiency in written and spoken English and Mandarin.
  • Ability to travel and work flexible hours.

12. Clinical Project Manager II/III (Portfolio and PMO Operations)

Sitting at the intersection of clinical operations and portfolio governance, the Clinical Project Manager II/III develops integrated resource and budget plans for all clinical projects within pharmaceutical, biotechnology, diagnostic, medical device, and CRO client portfolios, in collaboration with PMO leadership. Operating across project teams responsible for milestone achievement and KPI reporting, this role identifies critical-path risks, compiles portfolio-level project reports, and escalates resource and execution decisions to drive consistency and continuous improvement.


Operational Focus

  • Manage clinical project information to support project teams and leadership decision-making in collaboration with PMO leadership.
  • Ensure integrated resource and budget planning for all clinical projects within the portfolio.
  • Identify gaps, potential bottlenecks, and delays, and challenge assumptions to keep projects on schedule.
  • Oversee risk management including critical path analysis, risk assessment, and scenario creation and analysis.
  • Propose options to close gaps and get projects back on schedule.
  • Compile and communicate project reports to relevant stakeholders.
  • Ensure consistency, transparency, and optimization across the portfolio.
  • Implement best practices and foster continuous improvement through knowledge and experience exchange.
  • Define, measure, and report key performance indicators for assigned projects to measure and improve quality, efficiency, and effectiveness.
  • Manage meetings including setting agendas, organizing meeting time, and editing meeting minutes.


Position Requirements

  • BS or BA in science, engineering, or business administration, or equivalent combination of education and work experience.
  • Master's degree preferred.
  • Specific project management training or certification preferred.
  • 2 to 5 years of project management, product development, clinical operations, or relevant experience.
  • Knowledge of MS Project or a Portfolio Management Tool.
  • Experience in research and development preferred.
  • Experience in clinical operations preferred.
  • Previous experience with standard project management processes preferred.
  • Understanding of relevant design control or phased development processes preferred.
  • Stakeholder management, facilitation, and negotiation skills.
  • Ability to manage projects with ambitious milestones and activity or milestone achievement requirements.
  • Ability to escalate and drive management decisions related to project execution and resource needs.
  • Successful problem-solving skills with ability to coordinate project-related activities.
  • Strong written and oral communication skills.

Editorial Process and Content Quality

This content is developed by the Lamwork Editorial Team using structured analysis of real-world job data, skill requirements, and hiring patterns.

Research framework by Lam Nguyen, Founder & Editorial Lead.

Reviewed by Thanh Huyen, Managing Editor.

Learn more about our editorial standards.