Clinical Trial Manager - Late Phase

Hobson Prior have an exciting opportunity for a Clinical Trial Manager to join a thriving research-based pharmaceutical company. This position will be responsible for working with Clinical Program Managers to oversee the European component of global post-authorisation studies.

Job Responsibilities:

• Cooperate with internal and external contacts to ensure study progress.
• Will serve as the primary point of contact for CROs, addressing questions and resolving issues.
• Manages parts of allocated post-authorisation studies within set budgets and timelines.
• Contributes to advancement of RFPs and partake in selection of CROs/vendors.
• Manages CROs/vendors for allocated post-authorisation studies.
• Support the writing and review of documents including protocols, informed consents, case report forms, monitoring plans and clinical study reports.
• Maintain the study status in Clinical Trial Management System up to date for studies.
• Conduct study feasibility with internal Medical Affairs and Clinical Operations staff.

Key Skills:

• Understanding of post-marketing requirements and different types of post-authorisation safety and efficiency studies.
• 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.
• Capable of prioritising multiple tasks.
• Able to find resolutions to problems using regulations, guidelines, and investigator interaction.

Requirements:

• BSc in an applicable scientific branch.
• Clinical experience within the industry.
• Experience in the management of Phase IV and Non-Interventional studies.
• Experience in the review and oversight of Investigator Sponsored Trials would be advantageous.
• Excellent teamwork, communication, decision-making and organisational skills are necessary.

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.