Reference
CPMPR
Type
Permanent
Location
London
Salary
£70,000 - £80,000
Category
Research & Development
Sector
Pharmaceuticals / Biotechnology / FMCG

The Role

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.

Responsibilities

  • 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.

 

Experience 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
Name

E-Mail

Phone

Message


CHOOSE FILE