Clinical Project Manager (Contract)

Location: Remote or Hybrid (based on business needs)
Position Type: Contract
Industry: Biotechnology / Pharmaceutical / Clinical Research

Position Summary

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