Clinical Project Manager
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Hobson Prior are currently working with a leading biotech organisation in Cambridge who are seeking a Clinical Project Manager to join their expanding clinical team on a contract basis. You will have the opportunity to work across multiple rare disease therapeutic areas, using your clinical trials management expertise to progress the organisation's exciting development portfolio.
- You will manage the conduct of the organisations clinical trials from study design to close out (regional and global level).
- Ensuring the quality and scientific integrity of assigned studies in a Risk-Based Study Execution model.
- Performing risk assessments and developing risk mitigation plans to support study delivery.
- Contributing to development of Request for Proposals and participating in selection of CROs/vendors.
- Developing and maintaining study budgets.
- Vendor management for assigned studies.
- Setting up and coordinating Investigator Meetings.
- Tracking and communicating study status and issues to ensure project team goals are met.
- Contributing to the writing and review of clinical study documents (protocols, informed consents, case report forms, monitoring plans and clinical study reports).
- Providing input into cross functional documents (e.g. Safety related documents, Protocol Deviations and Issue Escalation processes, External Service Provider Oversight Plan, Filing and Archiving Plan).
- Representing as the primary point of contact for CROs, addressing questions and applying knowledge and expertise to resolve problems.
- Supporting the preparation of interim/final clinical study reports.
- Contributing to publications (abstracts, presentations, and manuscripts).
- Contributing to the clinical team's process improvement initiatives.
- Ability to resolve problems using national and international regulations, guidelines, and investigator interaction.
- Strong project planning/management and effective communication skills.
- Excellent teamwork, communication, decision-making and organizational skills.
- Life Science BSc or PhD qualification.
- A minimum of 5 years clinical study management experience in the pharmaceutical or biotech industry or equivalent.
- Proven experience managing global Phase II/III clinical studies from start-up to database lock.
- Experience in innovative trial design, adaptive trial design.
- You will have an interest/experience in rare disease biology, clinical unmet needs and current treatment paradigms.
- Interest in the application of digital technologies in clinical trials.
- Thorough up-to-date knowledge and understanding of ICH GCP, FDA and EMEA regulations.
- Experience in oversight of external vendors (CROs, central labs, etc.) essential.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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