Hobson Prior is seeking a Clinical Trial Manager to join a global biopharmaceutical company based in Uxbridge. A very patient-focused company, whose scientific research has resulted in 15 marketed products that are benefitting hundreds of thousands of people.
- 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.
- Sustains study timelines.
- Contributes to development of study budget.
- Partakes in the development of RFPs and contributes 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.
- Assists in determining the activities to support a project’s priorities within functional area.
- Organises and supervises all aspects of a clinical study.
- Assists Clinical Operations Europe Therapeutic Area Lead in their duties as applicable.
- Contributes to Clinical Operations Europe team activities & initiatives.
- Deliver strategic guidance of junior staff given acute insight on the monitoring of clinical sites.
- Ability to resolve problems using national and international regulations, guidelines, and investigator interaction.
- Able to understand, interpret, and explain protocol requirements to others.
- Capable of participating in multiple departmental or interdepartmental strategic initiatives under limited supervision.
- Have a general, functional expertise to support SOP development and implementation.
- Must have PAN European CT Experience and a minimum of 2/3 years.
- Must have multinational (including EU) clinical trials experience including study.
- Solid previous study management/coordination experience.
- Prior monitoring experience as site monitoring and/or co-monitoring will be required.
- In-depth knowledge and understanding of FDA and EU Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is 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.