Clinical Trials Manager
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Hobson Prior are currently seeking a Clinical Trials Manager to join a research-based biopharmaceutical company on a 12-month contract basis. Our client is very patient-focused, whose scientific research has benefitted hundreds of thousands of people by ensuring medications are available to those who could otherwise not afford them. This is a contract role located in Uxbridge, London.
- Manages European component of global Phase 2 3 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.
- May contribute to development of abstracts, presentations, and manuscripts.
- Ensures effectiveness of site budget/contract process.
- Conducts monitoring/co-monitoring as required.
- Assists in determining the activities to support a project's priorities within functional area.
- Coordinates and supervises all aspects of a clinical study.
- Under supervision, may design scientific communications within the company.
- Assists Clinical Operations Europe Therapeutic Area Lead in their duties as applicable.
- Contributes to Clinical Operations Europe team activities & initiatives.
- Must be able to generally understand, interpret, and explain protocol requirements to others.
- Must be able to prioritize multiple tasks.
- Ability to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
- Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
- Excellent communication and influence skills and ability to create a clear sense of direction is necessary.
- Inflammation therapeutic area experience would be advantageous but not essential.
- Must have multinational (including EU) clinical trials experience including study management/coordination.
- Must have solid previous study management/coordination experience.
- Must have monitoring experience as site monitoring and/or co-monitoring will be required.
- Thorough knowledge and understanding of FDA and EU Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is essential.
- Must have a general, functional expertise to support SOP development and implementation.
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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