Contract clinical trial manager - united kingdom, central london, london

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 .

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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