Clinical Project Manager

Clinical Project Manager – Global Studies

Job Summary: We are seeking a highly skilled and experienced Clinical Project Manager to oversee the planning, execution, and management of global clinical trials. The successful candidate will collaborate with cross-functional teams and manage Clinical Research Organisation (CRO) vendors to ensure the successful delivery of clinical studies, adhering to timelines, budgets, and regulatory requirements.

Key Responsibilities:

• Project Leadership: Plan, manage, and oversee the execution of global clinical studies from initiation to close-out, ensuring all activities align with study protocols, timelines, and quality standards.
• Vendor Management: Act as the primary point of contact for CROs and other external vendors, including negotiation, contracting, and performance oversight to ensure adherence to agreed deliverables.
• Regulatory Compliance: Ensure clinical studies comply with international guidelines (e.g., ICH-GCP), ethical standards, and local regulations.
• Risk Management: Identify potential project risks and implement effective mitigation strategies to resolve issues promptly.
• Budget Oversight: Manage project budgets, track expenses, and ensure cost efficiency throughout the clinical trial lifecycle.
• Stakeholder Collaboration: Liaise with internal stakeholders, including clinical operations, regulatory affairs, data management, and medical monitoring teams, to ensure alignment on project objectives.
• Documentation and Reporting: Oversee the preparation and review of essential documents (e.g., study protocols, informed consent forms, and trial master files) and provide regular status updates to senior leadership.
• Training and Development: Provide mentorship and guidance to project teams to ensure the effective execution of their roles and responsibilities.

Qualifications and Experience:

• Bachelor’s or Master’s degree in Life Sciences, Medicine, or a related field.
• Several years of experience in clinical trial management, with a strong track record in global studies.
• Extensive experience managing CRO vendors and external stakeholders.
• In-depth knowledge of ICH-GCP guidelines, regulatory requirements, and international clinical trial processes.
• Strong organizational and problem-solving skills with the ability to manage multiple projects simultaneously.
• Excellent communication and interpersonal skills to effectively collaborate with internal and external teams.

Preferred Skills:

• Experience working within a pharmaceutical, biotech, or CRO environment.
• Certification in Project Management (e.g., PMP) or Clinical Research (e.g., CCRP) is advantageous.

ABOUT PLANET PHARMA

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com

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