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Clinical Project Manager (Contract)Recruiting Advance • Cary, NC, United States
Clinical Project Manager (Contract)

Clinical Project Manager (Contract)

Recruiting Advance • Cary, NC, United States
16 days ago
Job type
  • Full-time
Job description

Clinical Project Manager (Contract)

We are seeking an experienced Clinical Project Manager to lead and oversee the execution of clinical trials from study start-up through closeout. The Clinical Project Manager will be responsible for ensuring studies are delivered on time, within budget, and in compliance with ICH-GCP guidelines, regulatory requirements, and company SOPs.

This individual will serve as the primary cross-functional leader, partnering with internal stakeholders, CROs, vendors, and investigative sites to drive successful clinical trial execution while proactively identifying and mitigating risks.

Key Responsibilities

  • Lead the operational management of Phase I-IV clinical studies.
  • Develop and maintain comprehensive study timelines, project plans, and study tracking tools.
  • Manage study budgets, forecasting, and resource planning.
  • Oversee CROs, vendors, and functional service providers to ensure quality deliverables and milestone achievement.
  • Conduct regular project team meetings and provide clear communication to internal leadership and external partners.
  • Monitor study progress, enrollment, data quality, and key performance metrics.
  • Identify project risks and develop mitigation strategies to maintain timelines.
  • Collaborate with Clinical Operations, Data Management, Biostatistics, Medical Monitoring, Regulatory Affairs, Clinical Supply, Pharmacovigilance, and Quality Assurance.
  • Support country and site start-up activities, including feasibility, regulatory submissions, contracts, and site activation.
  • Review monitoring reports, protocol deviations, enrollment trends, and study metrics to ensure overall study health.
  • Ensure inspection readiness and maintain compliance with GCP, FDA, EMA, and applicable global regulations.
  • Support study closeout activities, database lock, CSR preparation, and final vendor reconciliation.
  • Prepare executive-level project updates, dashboards, and status reports.

Qualifications

  • Bachelor's degree in Life Sciences, Nursing, or a related scientific discipline (advanced degree preferred).
  • 5+ years of clinical research experience with at least 3 years managing global or regional clinical trials.
  • Experience working within biotechnology, pharmaceutical, or CRO environments.
  • Strong understanding of ICH-GCP, FDA, EMA, and global regulatory requirements.
  • Experience managing CROs and external vendors.
  • Demonstrated success managing study timelines, budgets, and cross-functional teams.
  • Excellent project management, organizational, and problem-solving skills.
  • Strong communication and stakeholder management abilities.
  • Proficiency with CTMS, eTMF, EDC systems, Microsoft Project, Excel, and other project management tools.

Preferred Experience

  • Experience managing oncology, rare disease, CNS, immunology, infectious disease, or other specialty therapeutic area studies.
  • Global clinical trial management experience.
  • Experience supporting inspection readiness and regulatory audits.
  • PMP certification or equivalent project management training is a plus.

Core Competencies

  • Clinical Trial Management
  • Cross-Functional Leadership
  • Vendor & CRO Oversight
  • Budget & Financial Management
  • Timeline Development & Execution
  • Risk Assessment & Mitigation
  • Regulatory Compliance (ICH-GCP)
  • Project Planning
  • Strategic Decision-Making
  • Communication & Stakeholder Management
  • Problem Solving
  • Team Collaboration
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Clinical Project Manager (Contract) • Cary, NC, United States

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