Hobson Prior are currently seeking a Clinical Trial Manager for a research-based biopharmaceutical company in Uxbridge. Our client is very patient-focused, whose scientific research has benefitted hundreds of thousands of people by ensuring medications are available to those who could otherwise not afford them.

Job Responsibilities:

• Collaborate 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.
• Cooperates with cross-functional teams to ensure study progress.
• Act as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems.
• Manages aspects of assigned international post-authorisation studies within designated program budgets and timelines.
• Contributes to development of RFPs and participate in selection of CROs/vendors.
• Manages CROs/vendors for assigned post-authorisation studies.
• Support the writing and coordinate review of relevant documents including protocols, informed consents, case report forms, monitoring plans and clinical study reports.
• Develops good working relationships with internal late phase operational team and cross-functional staff internationally as required.
• Potential to participate in the preparation of interim/final clinical study reports.
• Potential to contribute to development of abstracts, presentations, and manuscripts.
• 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.

Key Skills:

• Ability to prioritise multiple tasks.
• Ability to contribute in multiple departmental or interdepartmental strategic initiatives under limited supervision.
• Resolve problems using national and international regulations, guidelines, and investigator interaction.
• Excellent teamwork, communication, decision-making and organisational skills are required.

Requirements:

• 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.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.