Torchora
Back to Home

Key Responsibilities and Required Skills for Clinical Project Manager

💰 $90,000 - $140,000

Clinical OperationsProject ManagementPharmaceuticalsBiotechnology

🎯 Role Definition

The Clinical Project Manager (CPM) is the operational lead for one or more clinical studies, accountable for delivering trials on time, on budget, and in compliance with ICH-GCP and global regulatory requirements. The CPM drives study start-up, site activation, vendor selection and oversight, risk-based monitoring plans, operational budgets, and cross-functional communications across Clinical Operations, Data Management, Safety, Regulatory Affairs, and Commercial teams. This role requires hands-on project management experience, strong clinical operations knowledge, and the ability to translate strategy into execution across internal and external stakeholders.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Clinical Research Associate (CRA) II / Senior CRA
  • Clinical Trial Coordinator / Clinical Research Coordinator (CRC)
  • Associate Project Manager / Clinical Trial Assistant (CTA)

Advancement To:

  • Senior Clinical Project Manager
  • Clinical Program Manager / Clinical Operations Lead
  • Head of Clinical Operations / Director of Clinical Development

Lateral Moves:

  • Vendor / CRO Project Manager
  • Clinical Vendor Oversight / Vendor Management Lead
  • Clinical Quality Assurance or Regulatory Affairs roles

Core Responsibilities

Primary Functions

  • Lead end-to-end operational planning and execution for clinical trials including study start-up, site activation, enrollment management, study conduct, close-out, and clinical study report deliverables, ensuring alignment with protocol, timelines, and budget.
  • Develop and maintain an integrated study-level project plan (Gantt) and detailed work breakdown structure, updating timelines and dependencies while communicating impacts to sponsors and steering committees.
  • Create, manage and forecast study budgets and resource plans (including FTEs, vendor budgets, and investigator grant payments); track spend vs. plan and implement corrective actions to manage budgetary risk.
  • Serve as the single point of contact for clinical operational matters, facilitating cross-functional governance with Clinical Operations, Data Management, Biostatistics, Safety/Pharmacovigilance, Regulatory, Medical Affairs and Commercial stakeholders.
  • Lead vendor selection, contracting, onboarding and operational oversight for CRO partners, central labs, IVRS/IWRS, imaging vendors, and other third-party suppliers; monitor vendor performance against SLAs and quality expectations.
  • Author and review essential operational documents including study management plans, monitoring plans, vendor charters, clinical development plans, risk management plans, and milestone reports.
  • Ensure trial conduct in compliance with ICH-GCP, local regulations, and sponsor SOPs; support inspections and audits and lead remediation activities in response to findings.
  • Build and implement site activation strategies, including feasibility assessments, site selection, site initiation visit planning and training; drive enrollment and retention initiatives to meet or exceed recruitment targets.
  • Oversee safety reporting processes in collaboration with Pharmacovigilance, ensuring timely detection, reporting and escalation of SAEs, SUSARs and other safety signals to regulatory authorities and ethics committees.
  • Manage study-level risk through proactive identification, documentation, and mitigation of operational, regulatory, and clinical risks using a risk-based quality management approach.
  • Coordinate data flow with Data Management and Biostatistics (EDC, database lock timelines, data cleaning, interim analyses) to ensure data quality and timely deliverables for interim and final analyses.
  • Oversee eTMF governance to ensure essential documents are filed, indexed and inspection-ready; conduct routine eTMF quality checks and close document gaps prior to milestones.
  • Prepare and present project updates, status reports and executive summaries to senior management, sponsors, and trial steering committees, including timeline, budget, enrollment, risks and mitigation plans.
  • Manage change control for protocol amendments, scope adjustments and timeline shifts, assessing operational impact, updating plans and communicating changes to impacted stakeholders and sites.
  • Design and implement monitoring strategies (on-site, remote, RBM / centralized monitoring) and partner with CRAs to ensure adequate site monitoring coverage and corrective actions.
  • Lead cross-functional launch and training programs including investigator meetings, site start-up materials, and study-specific training for internal teams and external partners.
  • Facilitate contract and budget negotiations with investigative sites and ensure timely execution of site agreements and payments to maintain study timelines.
  • Support clinical supply planning and logistics coordination in partnership with supply chain and vendors to ensure investigational product availability at sites and manage returns and reconciliation at study close.
  • Drive post-marketing and real-world evidence components when applicable, ensuring alignment of operational plans with PV, regulatory and commercial strategies.
  • Maintain complete and audit-ready trial documentation; coordinate responses to internal and external audits, regulatory inspections, and sponsor oversight activities.
  • Mentor and provide operational guidance to CRAs, CTAs and junior PMs; foster a culture of continuous improvement and cross-functional collaboration across the study team.
  • Facilitate lessons-learned sessions at study close to capture operational improvements, vendor performance feedback, and recommendations for future protocols.

Secondary Functions

  • Support ad-hoc operational data requests and collaborate with data teams on dashboards and trial metrics to improve enrollment forecasting and operational decision-making.
  • Contribute to organizational process improvement initiatives for clinical operations, including SOP refinement, template development, and automation of routine project management tasks.
  • Collaborate with business units to translate clinical development objectives into practical operational requirements and scalable study execution models.
  • Participate in sprint planning and agile ceremonies when working with internal R&D or digital health partners to iterate on clinical tools, eCOA, eConsent or other study technologies.
  • Provide input into vendor qualification and vendor risk assessments to support the organization's vendor management and compliance strategy.
  • Assist Regulatory Affairs in preparing regulatory submissions and responding to agency queries when study-level operational details are required.
  • Act as backup study lead for other programs as needed to ensure continuity of operations and knowledge transfer across the clinical portfolio.

Required Skills & Competencies

Hard Skills (Technical)

  • Proven expertise in clinical trial operations across phases I–IV, including experience with investigator-initiated studies, device trials or combination product studies when applicable.
  • Deep knowledge of ICH-GCP, FDA, EMA and country-specific regulatory requirements and experience supporting inspections and submissions.
  • Strong project management capabilities: milestone planning, resource allocation, critical path analysis, change control and earned value or budget management techniques.
  • Vendor and CRO management experience: RFP development, SOWs, KPIs, SLAs, performance management and remediation.
  • Proficiency with Clinical Trial Management Systems (CTMS) such as Veeva, Oracle, or Medidata and eTMF systems (e.g., Veeva Vault eTMF, PhlexGlobal).
  • Hands-on experience with EDC systems (Medidata Rave, Oracle Clinical, REDCap) and familiarity with IRT/IVRS systems for randomization and supply management.
  • Familiarity with risk-based monitoring (RBM) frameworks and centralized monitoring tools and techniques.
  • Operational knowledge of safety reporting and PV interfaces, including SAE/SUSAR workflows and timelines.
  • Experience preparing and managing study budgets, investigator payments and site contracting.
  • Competence in project tools and analytics: Microsoft Project / Smartsheet, Excel (pivot tables, financial modeling), PowerPoint, and dashboard tools (Tableau, Power BI).
  • Experience supporting data management and statistical milestones including database lock, interim analyses and DMC/DSMB interactions.
  • Knowledge of clinical supply planning and logistics for IMP/device lifecycle management.
  • Certifications desirable: PMP, PMI-ACP, ACRP, SOCRA, or other clinically relevant project management or clinical research certifications.

Soft Skills

  • Strong leadership and people-management ability with a track record of building motivated cross-functional teams and mentoring junior staff.
  • Excellent written and verbal communication skills — able to translate technical and regulatory details into clear, stakeholder-specific updates and executive summaries.
  • High level of organization and attention to detail with the ability to manage simultaneous studies and competing priorities.
  • Advanced problem-solving and decision-making skills; comfortable making trade-offs and escalating issues when necessary.
  • Stakeholder management and negotiation skills — experience aligning sponsors, investigators and vendors to meet study objectives.
  • Adaptability and resilience — proven ability to operate in fast-paced, ambiguous environments common to biotech and early-phase programs.
  • Strong customer-focus and site-centric mindset to support investigator relationships and drive enrollment.
  • Analytical mindset and metric-driven approach to measure performance and drive continuous improvement.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor's degree in life sciences, nursing, pharmacy, public health, or related scientific discipline.

Preferred Education:

  • Advanced degree (MS, MPH, PharmD, or MSc) in clinical research, health sciences or a related field.
  • Project management certification (PMP, PMI-ACP) or clinical research certification (ACRP, SOCRA) preferred.

Relevant Fields of Study:

  • Clinical Research / Clinical Sciences
  • Nursing / Healthcare
  • Pharmacy / Pharmacology
  • Life Sciences (Biology, Biochemistry)
  • Public Health / Health Sciences

Experience Requirements

Typical Experience Range: 4–8+ years in clinical research with at least 2–4 years in a project management or study lead role.

Preferred:

  • Prior experience managing global, multi-center Phase II–III clinical trials or late-stage device studies.
  • Experience working with or within CROs, biotech or pharmaceutical sponsors and demonstrated success driving enrollment in competitive therapeutic areas.
  • Prior exposure to regulatory inspections, audit responses and working with Data Monitoring Committees (DMCs) or Institutional Review Boards (IRBs)/Ethics Committees.
Explore More Careers