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.

Responsibilities:

• 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.

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