My client, a hyper growth T Cell therapy business in London is currently looking to expand their Clinical Operations team with the addition of a Clinical Project Manager / Senior Clinical Project Manager as they fast approach 1st in human studies.
- Lead the Clinical Study Team to drive effective decision making and ensure Sponsor oversight of the assigned studies from study planning, start up, conduct, and close-out.
- Develop project plans and defining operational guidelines for each study.
- Act as the main point of contact for the CRO and vendors
- Organise and manage internal team meetings, study-specific meetings, and meetings with sponsors/vendors/partners as applicable Oversee the quality and scientific integrity of clinical operations for studies at a global level.
- Maintain oversight of CRO-held eTMFs.
- Design and execute clinical monitoring oversight strategy
- Identify critical project success factors including probability, impact of potential project risks and respective mitigations.
- Establishes project metrics and project report schedules. Develop, track, and report study specific KPIs for each study.
- Manages adherence to project contracts and assists in the identification and development of scope change documents.
- Monitors project status, budget expenditures, and identifies problems, and recommend solutions.
- Coordinates assignment of needed resources for project conduct and completion with functional area leaders.
- Other duties may be assigned as required.
- 4+ years’ work experience as Clinical Project Manager/ Clinical Study Manager/ Clinical trial Manager or equivalent gained in a biotech, pharmaceutical or CRO company.
- Experience and knowledge of managing ATIMP projects across multiple countries and time zones
- Experience in oversight of external vendors (e.g. CROs, central labs, logistics vendors, etc.).
- Experience of working internationally, collaborating, and leading cross-functional teams in a fast-paced team environment.
- Experience in immunology and solid organ transplant therapeutic area is a plus.
- Batchelor’s or Master’s degree in Life Sciences