Clinical PM Consultant

Walker Cole International is currently partnered with a Biotech searching for a Freelance Clinical Project Manager in Europe for an initial 6-month contract commencing in 2026 to support a Phase III clinical trial.

Key Responsibilities:

• Lead the global planning, execution, and delivery of a Phase III clinical trial, ensuring adherence to timelines, budget, and quality standards.
• Oversee CROs and external vendors, ensuring performance, compliance, and contractual deliverables are met.
• Ensure compliance with ICH-GCP, EU Clinical Trial Regulation (EU CTR), and applicable international regulatory requirements.
• Manage cross-functional teams, including Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Medical Affairs, and Pharmacovigilance.
• Drive study start-up, site activation, patient recruitment, and retention strategies to meet enrolment targets.
• Monitor study progress, identify risks, and implement proactive mitigation plans.
• Provide regular updates, metrics, and status reports to senior leadership and key stakeholders.
• Maintain oversight of Trial Master Files (TMF/eTMF) and ensure inspection readiness for regulatory authorities.
• Support database lock, statistical analysis, and Clinical Study Report (CSR) preparation.
• Lead audit and inspection activities, ensuring high-quality documentation and compliance throughout the study lifecycle.

Required Qualifications:

• Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
• Minimum of 7–10 years of experience in clinical research, including significant project management experience.
• Proven track record managing large-scale, multicentre Phase III clinical trials within a biotech, pharmaceutical, or CRO environment.
• Strong knowledge of ICH-GCP, EU CTR, and global regulatory requirements.
• Demonstrated experience managing CROs, vendors, and global stakeholders.
• Familiarity with CTMS, eTMF, and EDC systems.
• Excellent leadership, organisational, and communication skills.
• Proficiency in Microsoft Office Suite.

Preferred Qualifications:

• Advanced degree (MSc, MPH, or PhD) in a relevant discipline.
• Project Management certification such as PMP or PRINCE2.
• Experience in therapeutic areas such as oncology, immunology, rare diseases, or cardiovascular medicine.
• Experience managing global, multicentre trials across the US and Europe.
• Familiarity with risk-based monitoring (RBM) and decentralised clinical trials (DCTs).
• Prior experience working within a small or mid-sized biotech environment.

Contract Details:

• Start Date: April 2026
• Work Schedule: Full-time
• Rate: €100–€150 per hour (dependent on experience level)
• Duration: 6 months (with likely extension)
• Location: Europe – Remote

Clinical Project Manager | Clinical PM | Phase III | Late-Phase Trials | Clinical Operations | Global Clinical Trials | Contract | Contractor | Biotech | Biopharma | EU CTR | Remote Europe