Clinical Trials Manager

Proclinical is seeking a Clinical Trials Manager to oversee the execution of clinical studies, particularly in the oncology field. This role involves managing various components of clinical trials, ensuring compliance with regulatory guidelines, and contributing to the development of study logistics and plans. The position requires a strong focus on data analysis and primary analysis, with an emphasis on solid tumours.

Responsibilities:

• Manage all components of small clinical studies, including Phase I studies.
• Lead contract research organization (CRO) and vendor selection, managing interactions and deliverables.
• Serve as the key operational contact, overseeing site evaluation, initiation, and close-out visits.
• Develop study logistics and clinical study plans.
• Manage study timelines, documentation, and communications.
• Participate in and manage project meetings and conference calls with CROs, vendors, and cross-functional teams.
• Contribute to SOP development and special projects, optimizing project efficiencies.
• Provide input into study protocols, case report forms, informed consents, study plans, and presentations.
• Oversee study sites/regions and review regulatory documents for compliance.
• Present at internal or external meetings, such as investigator meetings.
• Assist in the preparation of safety, interim, and final study reports, resolving data discrepancies.
• Identify potential operational challenges and collaborate on solutions.
• Assist in training new or less experienced colleagues.
• Ensure compliance with established practices, policies, processes, and regulatory requirements.

Key Skills and Requirements:

• Previous working history within life sciences.
• Experience leading or managing clinical studies and project teams.
• Experience managing the work of external vendors.
• Ability to manage full cycle study management, from start-up to close-out.
• Advanced knowledge of study management best practices and tools.
• Thorough knowledge of FDA, EMA, ICH guidelines, and GCP.
• 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.

If you are having difficulty in applying or if you have any questions, please contact Joshua Bye at j.bye@proclinical.com

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.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.