Contract Clinical Trial Manager

Proclinical is seeking to hire a Contract Clinical Trial Manager for a biopharmaceutical company. This individual will be based in London and responsible for the execution of all phases in clinical trials, across all therapeutic areas, around the world.

Job Responsibilities:

• Manages European component of global Phases II-III outsourced studies managed by a Clinical Program Manager.
• Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.
• Maintains study timelines.
• Contributes to development of study budget.
• Contributes to development of RFPs and participate in selection of CROs/vendors.
• Manages CROs/vendors.
• Coordinates review of data listings and preparation of interim/final clinical study reports.
• Ensures effectiveness of site budget/contract process.
• May be asked to train CROs, vendors, investigators, and study coordinators on study requirements.
• Conducts oversight monitoring visits as required.
• Interacts with cross-functional teams internally and externally to ensure trial progress.

Skills and Requirements:

• Educated to degree level or above within a scientific discipline
• Oncology experience is highly desired.
• Must have multinational (preferably EU) clinical trials experience including study management/coordination.
• Monitoring experience highly desirable but not essential as site oversight monitoring visits will be required.
• Thorough knowledge and understanding of FDA and EU Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
• Must be able to generally understand, interpret, and explain protocol requirements to others.
• Ability to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
• Must have a general, functional expertise to support SOP development and implementation.
• Core Values
  • Integrity (always doing the right thing)
  • Teamwork (collaborating in good faith)
  • Excellence (working at a high level of commitment and capability)
  • Accountability (taking personal responsibility)
  • Inclusion (encouraging diversity)

If you are having difficulty in applying or if you have any questions, please contact Matthew Pike at +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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