Contract Clinical Trials Manager
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A leading biopharmaceutical organisation with a solid commercial portfolio of life-saving drugs within a number of therapy areas have a new Contract Clinical Trials Manager job opportunity at their offices in London. The company has a growing pipeline of investigational drugs and approximately 5,000 employees in offices across four continents.
The Clinical Operations team is responsible for the execution of all Phase 1-3 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures that all clinical trial activities are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of the company's products. For the team based in our European Headquarters in Uxbridge, we are looking for a Clinical Trial Manager to work within the Inflammation Disease therapeutic area.
Job Responsibilities:
- Works with Clinical Program Managers to manage the European component of global clinical trials and/or the entire process of a local clinical trial, with the ability to identify issues and adapt to changes.
- Interacts with cross-functional teams internally and externally to ensure trial progress.
- Will incorporate study logistics and planning to accomplish study objectives.
- Will serve as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems.
- 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 be able to generally understand, interpret, and explain protocol requirements to others.
- Must be able to prioritize multiple tasks.
- Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
- Must have a general, functional expertise to support SOP development and implementation.
- Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
- Strong communication and influence skills and ability to create a clear sense of direction is necessary.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Pike on +44 207 4400 639 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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