Clinical Trial Manager - Late Phase Clinical Operations

Gilead

Uxbridge, United Kingdom

Job Description

An exciting position has arisen to join the Clinical Operations team based within the European Headquarters in Stockley Park, Uxbridge, as a Clinical Trial Manager to be responsible for the management of Non-Interventional Studies (i.e. retrospective/prospective observational studies, patient registries, HCP/patient surveys) studies and/or Managed Access Programs across different therapeutic areas and global/regions.

Manages aspects of assigned Global and/or Regional Non-Interventional Studies including regulatory commitments and/or Managed Access Programs within designated study 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 Non-Interventional Studies and/or Managed Access Programs.
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 and other study plans and clinical study reports.
Maintains study timelines and communicates adjustments where necessary.
Develops good working relationships with global Late Phase operational team and global cross-functional staff including Medical Affairs, Pharmacovigilance, Real World Evidence, Project Management, Regulatory, Clinical Data Science and Clinical Development 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 GILDA up to date for assigned Studies.
Participate in or lead departmental strategic initiatives.
Conduct study feasibility in conjunction with internal Medical Affairs and/or Real World Evidence and Clinical Operations staff and/or external collaborators or CROs.
Contributes to Clinical Operations global 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 organisational perspective.

Specific Responsibilities:

Works with Clinical Program Managers to manage global or regional Non-Interventional Studies and/or Managed Access Programs, with the ability to identify and manage issues/risks and adapt to changes.
Interacts with cross-functional teams internally and externally to ensure Non-Interventional Studies/Managed Access Program 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 Non-Interventional Studies highly preferential.
Knowledge of post-marketing requirements and different types of Non-Interventional studies including 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, FDA and EMEA regulations and guidelines governing Non-Interventional Studies and/or Managed Access.
Must be able to prioritise 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 organisational skills are required.
Occasional travel may be required.

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