Hobson Prior are recruiting for a Senior Clinical Trial Management Associate to join a research-based biopharmaceutical company in Uxbridge on a contract basis. 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:

For Collaborative and Investigator-Sponsored Research projects:

• Act as the key operational contact with external investigators and internal stakeholders.
• Manages assigned studies by establishing strong partnerships with external investigators and collaborators to ensure CO and ISR Agreements for financial or product support are processed in a timely manner and to a high quality.
• Evaluates scientific proposals or protocols to identify logistical, regulatory and safety elements and implications.
• Proactively recognises operational challenges and in collaboration with senior team members provides and implements solutions to ensure studies remain on track.
• Maintains efficient collaboration with company's Development Business Operations team and external investigator/study representative to ensure contracts are executed in a timely manner.
• Supports study drug planning and shipping activities with Materials & Logistics.
• Communicates and collaborates with other functional groups including but not limited to Medical Affairs, Regulatory Affairs, Development Business Operations, Materials and Logistics (M&L), and Global Patient Safety to ensure efficient management of study activities.
• Forecasts, tracks and reports CO and ISR milestones, as well as verifies completeness of the study milestones prior to invoice payment.
• Provides monthly study updates to the appropriate internal stakeholders.
• Any other assigned duties.

For the organisation's Sponsored Studies:

• To provide administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
• Under supervision may assist in development and review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports.
• Under supervision may have country/site oversight for ensuring timely start-up, vendor oversight of monitoring activities and data quality review.
• Assists in preparation of progress reports, interim and final study reports, including resolving data discrepancies.

Key Skills:

• Excellent verbal, written, interpersonal and presentation skills are required.
• Strong planning, time management, organizational, and administrative skills.
• Learning ability with demonstrated flexibility required to maintain a fast pace.
• Ability to maintain internal/external networking and cross-functional collaboration.

Requirements:

• Typically requires a BSc in a relevant scientific discipline and relevant clinical experience in the pharmaceutical or health care industry or equivalent.
• Good knowledge and understanding of ICH GCP, FDA and EMEA regulations and guidelines applicable to post-authorization studies.
• Must be proficient with MS Word, PowerPoint, Outlook, and Excel.
• Must be familiar with routine medical/scientific terminology.
• Able to participate in departmental or interdepartmental strategic initiative under general supervision.

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.