An exciting contract position has arisen to join the Clinical Operations team at a research-based biopharmaceutical company in Uxbridge. This position will be accountable for the management of post-authorisation studies and Investigator Sponsored Research across different therapeutic areas.

Please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities:

• You will work 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.

Key Skills:

• Must be able to generally understand, interpret, and explain protocol requirements to others.
• Must be able to prioritize multiple tasks.
• Ability to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
• Ability to resolve problems using national and international regulations, guidelines, and investigator interaction.
• Excellent teamwork, communication, decision-making and organizational 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.
• Prior 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.
• 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 then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.