Global Clinical Trial Management Associate
A fantastic contract job has arisen for a Global Clinical Trial Management Associate in the UK. You will join a large biotech working remotely and focusing on late phase studies. In this role you will be expected to provide support and oversight of Investigator Sponsored Trials including Fair Market Value and feasibility assessment, contract milestone advice, tracking and publication follow-up as required.
- Manages aspects of assigned international post-authorisation studies within designated program budgets and timelines.
- Contributes to development and maintenance of study budgets.
- Contributes to development of RFPs and participate in selection of CROs/vendors.
- Manages CROs/vendors for assigned post-authorisation studies.
- Communicates project status and issues and ensure project team goals are met.
- Contributes to the writing and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans and clinical study reports.
- Maintains study timelines and communicates adjustments where necessary.
- May participate in the preparation of interim/final clinical study reports.
- May contribute to development of abstracts, presentations, and manuscripts.
- Keep study status in Clinical Trial Management System up to date for assigned studies.
- Under supervision, may participate in or lead departmental strategic initiatives.
- Conduct study feasibility in conjunction with internal Medical Affairs and Clinical Operations staff and/or external collaborators or CROs.
- Participate in CRO calls as necessary.
Skills and Requirements
- BS/BA degree in healthcare / scientific field preferred
- Excellent knowledge of Good Clinical Practices (GCP, GCP).
- Demonstrate a very strong ability to adapt, organise and manage priorities.
- Your thoroughness, your discretion and your sense of confidentiality are recognised and appreciated.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.