Senior Clinical Project Manager
Proclinical are recruiting for a Senior Clinical Project Manager to join a biotech organisation. This role is on a permanent basis located in London with flexible working available working.
- Guide the operational management and oversight of external providers at the study/program level.
- Monitor and handle the study budget(s) and contracts guaranteeing evaluations, invoice tracking and reporting to senior management in a timely manner.
- You will develop and supervise maintenance on pertinent internal clinical databases and project plans.
- Review and collaborate with management to select clinical contract research organisations, external suppliers and consultants.
- Acknowledge study performance problems and enrolment issues when required.
- Offer operational contributions to documents which may involve synopses and protocols, investigator brochures, clinical development plans, clinical study reports and briefing papers.
- The ideal candidate will attend clinical development meetings and any other meetings requested by senior management.
- Partake in writing, supervising and preservation of SOPs and processes assuring clinical studies meet all ICH GCP regulations and appropriate guidelines.
- Other duties may be assigned.
Key Skills and Requirements:
- Educated to a degree level in a life science discipline.
- Know-how of ICH GCPs and GVPs.
- Demonstrable experience in a clinical project manager role within a biotech or pharmaceutical organisation guiding clinical studies, ideally on an international scale.
- A background in a similar role or function, distributing clinical studies with quality and within budget all in a timely manner.
- Scientific knowledge with expertise on autoimmune illnesses would be ideal.
- Able to partake in and/or produce key study documentation such as clinical study synopses, protocols, clinical study reports, etc.
- Familiarity with selecting and handling vendors as well as handling phase I - III studies.
- Willing to travel for business needs.
- Keen to assume the initiative and get involved in planning, resolving issues and implementing work within a team setting.
- Work efficiently within a dynamic matrix-team setting.
- Interpersonal and analytical capabilities.
- Fluency in the English language.
- Communication and presentation sills both verbally and in writing.
- Capable of maintaining resilience, is a fast learner and able to produce outcomes to deadlines within a constant-altering, pressuring setting.
- Eager about clinical development, exhibiting commitment to preserving standards at the highest-possible level.
- Computer literacy.
- An organised individual with the ability to manage both internal and external teams.
- Leadership skills.
- Works well independently.
If you are having difficulty in applying or if you have any questions, please contact Matthew Pike on +44 207 4400 639.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.