Clinical Trial Management Associate

Hobson Prior are currently seeking a Clinical Trial Management Associate for a research-based biopharmaceutical company on a contract basis. Our client is very patient-focused and their research has benefitted many thousands of people by ensuring medications are available to those who could otherwise not afford them.

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

Key Responsibilities:

• In this role, you will be serving as the key operational contact with external investigators and internal stakeholders.
• You will be evaluating scientific proposals or protocols to identify logistical, regulatory and safety elements and implications.
• Responsible for managing 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.
• Proactively identifies 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 Clinical Contracts and Finance (CCF) 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 Pharmacovigilance and Epidemiology (PVE) 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.
• Ensures all budget or drug supply modifications are appropriately approved, documented and tracked.
• Implements working processes to promote high quality, efficient, and compliant systems for Late Phase research management.
• Supports and implements Clinical Operations Quality Initiatives.
• Maintains internal Clinical Operations and Medical Affairs databases and clinical study data and document repositories.
• Performs administrative duties in a timely manner as assigned.

Key Skills:

• Outstanding planning, time management, organisational, and administrative skills.
• Excellent verbal, written, interpersonal and presentation skills are required.
• Demonstrates core values of strong teamwork and accountability with ability to prioritize competing timelines and deliver excellent results.
• Learning ability with demonstrated flexibility required to maintain a fast pace.
• Tenacity and perseverance to ensure a high level of customer service.
• Able to maintain internal/external networking and cross-functional collaboration.
• Demonstrates a high sense of urgency and commitment to excellence in the successful execution of deliverables.
• Must be able to prioritise multiple tasks, and accomplish goals using well-defined instructions and procedures.

Requirements:

• The ideal candidate requires a BSc in a relevant scientific discipline and relevant clinical experience in the pharmaceutical or health care industry or equivalent.
• Must be proficient with MS Word, PowerPoint, Outlook, and Excel.
• Must be familiar with routine medical/scientific terminology.
• Strong knowledge and understanding of ICH GCP, FDA and EMEA regulations and guidelines applicable to post-authorization studies.
• Must be 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.