An exciting contract position has arisen to join my client’s Clinical Operations team based in their HQ in Uxbridge, as a Contract Clinical Trial Manager to be responsible for the management of post-authorisation studies and Investigator Sponsored Research across different therapeutic areas.
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.
Provide operational management of Post-Authorisation Studies:
* 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.
* Develops good working relationships with the US late phase operational team and cross-functional staff internationally as required.
* 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.
* Conducts Monitoring/co-monitoring as required.
* Contributes to Clinical Operations International team activities & initiatives.
* May serve as a resource for others within the company for clinical trials management expertise.
* Under general supervision, is able to examine functional issues from an organizational perspective.
* Works with Clinical Program Managers to manage the regional 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.
* Interacts with cross-functional teams internally and externally to ensure study progress.
* Will serve as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems.
Experience, knowledge and skills:
* Typically requires a BSc in a relevant scientific discipline and relevant clinical experience in the pharmaceutical or health care industry or equivalent.
* Previous experience in the management of Phase IV and Non-Interventional studies essential.
* Experience in the review and oversight of Investigator Sponsored Trials desirable.
* Knowledge of post-marketing requirements and different types of post-authorisation safety and efficacy studies.
* Must be able to generally understand, interpret, and explain protocol requirements to others.
* Good knowledge and understanding of ICH GCP, GVP, FDA and EMEA regulations and guidelines applicable to post-authorization studies.
* Must be able to prioritize multiple tasks.
* Must be able 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 teamwork, communication, decision-making and organizational skills are required.
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