Hobson Prior is seeking a Clinical Trials Manager to oversee the execution of clinical trials across various therapeutic areas. This role involves managing a geographical region or multiple components of larger studies, typically Phase I studies or other smaller studies. The successful candidate will be responsible for defining and incorporating study logistics and study plans to achieve clinical study objectives and may also participate in strategic initiatives.

Responsibilities:

• Oversee all aspects of small clinical studies, including Phase I studies.
• Select and manage contract research organizations (CROs) and vendors, and manage all interactions and deliverables from relevant CROs and vendors.
• Serve as the key operational contact for studies; overseeing site evaluation, initiation, and close-out visits in addition to routine monitoring visits, either directly or through CROs.
• Develop the study logistics and clinical study plan for assigned clinical studies.
• Manage study timelines, including documentation and communications.
• Participate in and manage project meetings and conference calls with CROs, other vendors and cross-functional teams.
• Contribute to SOP development and/or participate in special projects. Develop tools and processes that optimize project efficiencies and effectiveness.
• Provide input into study protocols and case report forms, author informed consents, study plans, and presentations.
• Oversee study sites/region and review routine regulatory documents to ensure that CROs are in compliance with protocols, regulatory requirements, SOPs, and monitoring plans.
• May be required to present at internal or external meetings (i.e., investigator meetings).
• Lead or assist in the preparation of safety, interim and final study reports, including resolving any data discrepancies.
• Identify potential operational challenges and collaborate with other Clinical Operations' colleagues to provide solutions to ensure study execution remains on track to defined protocols, budgets and timelines.
• Assist in training new or less experienced colleagues.
• Ensure own work complies with established practices, policies and processes, and any regulatory or other requirements.

Key Skills and Requirements:

• Relevant clinical or related experience in life sciences.
• Experience managing the work of external vendors.
• Ability to learn quickly.
• Flexibility and adaptability to change, ability to move between projects easily and provide support/expertise where needed.
• Ability to manage any component of full cycle study management, from start-up to close-out.
• Advanced knowledge of study management best practices and tools.
• Thorough knowledge of FDA, EMA, and other applicable national regulations, ICH guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies.
• Familiarity with standard medical / scientific terminology.
• Clear and concise communication skills.
• Ability to support a team-oriented, highly-matrixed environment.
• Ability to execute multiple tasks as assigned.
• Willingness to travel when needed.

Interested or know someone who might be? Reach out to ­­­­William Tyler using the following:

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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.