Contract Clinical Trial Manager, Late Phase
A vacancy has arisen for a Contract Clinical Trial Manager, Late Phase with an internationally renowned pharmaceutical company, based in their London office. This organisation is known for its solid commercial portfolio of life-saving drugs within a number of therapy areas, along with a growing pipeline of investigational drugs and an unmatched patient access program. This is an exciting opportunity to work with a leading pharmaceutical organization and support their innovative impact on the healthcare field. This will be a 12 month rolling contract.
- Managing aspects of assigned international post-authorisation studies within designated program budgets and timelines.
- Contributing to the development and maintenance of study budgets.
- Contributing to the development of RFPs and participate in selection of CROs/vendors.
- Managing CROs/vendors for assigned post-authorisation studies.
- Communicating project status and issues and ensuring project team goals are met.
- Contributing to the writing and coordinating reviews of relevant documents including protocols, informed consents, case report forms, monitoring plans, and clinical study reports.
- Maintaining study timelines and communicating adjustments where necessary.
- Developing good working relationships with the company's late phase operational team and cross-functional staff internationally as required.
- Participating in the preparation of interim/final clinical study reports.
- Contributing to the development of abstracts, presentations, and manuscripts.
- Keeping study status in Clinical Trial Management System up to date for assigned studies.
- Participating in or lead departmental strategic initiatives.
- Conducting the study feasibility in conjunction with internal Medical Affairs and Clinical Operations staff, external collaborators, or CROs.
- Participating in CRO calls as necessary.
- Conducting Monitoring/co-monitoring as required.
- Contributing to Clinical Operations International team activities & initiatives.
- Serving as a resource for others within the company for clinical trials management expertise.
- Working with Clinical Program Managers to manage the European component of global post-authorisation studies and/or the entire process of an EU post-authorisation study, with the ability to identify issues and adapt to changes.
- Interacting with cross-functional teams internally and externally to ensure study progress.
- Serving as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems.
Skills and Requirements:
- Demonstrable experience in a similar or relevant capacity.
- Relevant or transferable education.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Matthew Pike at +44 207 440 0639 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing 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.