Clinical Trial Management Associate

Proclinical is excited to partner with a leading biotechnical company that focuses on innovative medicines that treat rare genetic, cardio-metabolic, and ocular diseases. This organisation is seeking to appoint a Contract Clinical Trial Management Associate, who will join the company's UK-based team on a contract basis.

The Clinical Trial Management Associate will oversee study management and monitoring of assigned projects in accordance with company SOPs, Good Clinical Practice, International Conference on Harmonisation (ICH), Harmonised Tripartite Guidelines, local regulations, and additional sponsor requirements. The CTM Associate will participate in company, departmental, and project team meetings, and will report into Clinical Operations.

Job Responsibilities:

• Demonstrating study and clinical investigative site management according to Good Clinical Practices, ICH Guidelines, local regulations, and Alnylam SOPs.
• Creating and providing input into study management requirements and tools, monitoring tools and manuals, and training tools.
• Maintaining a thorough understanding of current monitoring practices, applicable regulatory requirements, and guidelines.
• Performing study oversight and study site visits to ensure regulatory and study requirements are being fulfilled.
• Reviewing study records including case report forms, consent forms, and other materials, and is versed in remote monitoring approaches.
• Serving as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols;
• Providing input, tracking progress, and working to implement corrective action plans for study and individual site recruitment and retention plans.
• Developing and maintaining collaborative relationships with investigational sites study teams, CRO teams, and vendor teams.
• Producing quality and timely study documentation, including trip reports, tracking, and site/sponsor communications in accordance with standard operating procedures.
• Maintaining accurate and timely Sponsor/site communication and correspondence.
• Ensuring IMP and supplies accountability.
• Participating in company, departmental, and project team meetings.

Skills and Requirements:

• BS/BA degree required; degree in healthcare scientific field preferred.
• 3 years monitoring / CRO management or CRO oversight experience of clinical trials, including site management, or equivalent.
• Knowledge of ICH GCP guidelines and the expertise to review and evaluate medical data.
• Capable of travelling up to 35%.
• Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solve problems.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, influence, and leadership.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency in MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Matthew Pike on +44 207 440 0639 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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