Clinical Project Manager
Mundipharma
Cambridge, United Kingdom
We are looking for an experienced Clinical Project Manager to join our Global Clinical Operations team. This is a vital role responsible for leading and managing international clinical trials across multiple phases and therapeutic areas.
This opportunity is well-suited to individuals from biotech or smaller, agile organizations who thrive in a multi-tasking environment, as well as those with experience from larger pharmaceutical companies who understand the dynamics of cross-functional global collaboration.
Role and Responsibilities
- Lead and manage clinical trials (Phase I through Post-Marketing Surveillance) to ensure delivery on time, within budget, and to quality standards in compliance with ICH-GCP and company SOPs.
- Work across various therapeutic areas and phases, managing external CRO partners and internal cross-functional teams.
- Input into the strategic direction of Clinical Operations, including CRO/vendor selection and process improvement initiatives.
- Oversee and prepare study documentation, including protocols, guidelines, study reports, and updates.
- Attend site visits with CRO Clinical Research Associates (CRAs) to support recruitment, quality, and protocol adherence.
- Monitor and track clinical study budgets, vendor contracts, and investigator payments.
- Contribute to clinical development plan discussions, scenario planning, and budget forecasting.
- Mentor and oversee activities of Associate Clinical Project Managers as needed.
What You’ll Bring
- BSc or equivalent in a science discipline is essential.
- Minimum of 4 years’ experience managing international clinical trials across various phases and therapeutic areas.
- Deep knowledge of ICH-GCP and global clinical operations processes.
- Proven ability to manage global CROs and cross-functional study teams.
- Strong prioritization skills, high attention to detail, and comfort managing multiple projects.
- Experience in smaller biotech or dynamic environments, with the ability to adapt and multitask.
- Background in large pharma advantageous, bringing understanding of structured processes and global collaboration.
- Excellent written and verbal communication skills.
Communication and Stakeholder Management
- Collaborate closely with the Principal Clinical Project Manager and Head of Clinical Operations for study oversight and process improvements.
- Liaise with CRO project managers for status reviews, issue resolution, and documentation.
- Coordinate with internal study teams and matrixed stakeholders to ensure seamless delivery of trials.
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