Jim Gleeson is recruiting for a Clinical Project Manager to join an innovative biotechnology company with a large and diverse product pipeline. You will need to work from their central London offices for two days a week. Competitive salary and benefits package.
As Clinical Project Manager you will play a lead role in planning, co-ordinating and the efficient execution of multi-centre phase I and II oncology clinical trials or programs, ensuring delivery of associated activities to time, cost and quality.
Key duties will include:
- Working with internal and external teams and providers to ensure clinical trials and development plans are initiated, managed and delivered in line with company strategy
- Writing study protocols and related study documents, from the initial scientific discussion
- Contributing to regulatory filing packages including but not limited to briefing books, regulatory submissions and responses
- Managing the selection process for vendors including CRO/lab/DM/PV
- Taking on the role of Asset Lead, working with the cross functional team from across the company to manage and accelerate the development program
- Working with the Head of CMC to ensure drug supply for clinical activities
- Ensuring clinical trials/program meets all GCP/ICH Guidelines and are inspection ready, via oversight of TMF
As Clinical Project Manager you will require:
- An advanced degree in life sciences, PhD desirable
- Extensive experience of running multi-centre, international clinical trials in oncology or similar experience of working across various therapeutic areas
- Extensive biotech experience
- Phase I and II trial experience with ability to work-up assets in preparation for IND/CTA regulatory submission
- Vendor selection and management experience
- Excellent communication and presentation skills
- Willing to travel internationally if required
Entitlement to work in the UK is essential. For more information please contact Jim Gleeson on 01438 842973 or email firstname.lastname@example.org. Please quote reference 52736 in all correspondence.