Clinical Trial Manager
ProClinical, in support of our client, are seeking an individual to fill the role of Clinical Trials Manager (CTM), based in Boston, MA. The successful candidate will be fundamental to the efficient execution of trials and will support overall compliance with Good Clinical Practices (GCP) and company Standard Operating Procedures (SOPs).
- Lead combined study team(s) ensuring effective cross-functional teamwork among team members including both internal and external stakeholders.
- Implement and monitor progress against project plans and revise as necessary.
- Track and report on trial progress.
- Monitor trial assumptions, schedule and costs.
- Lead quality control and risk assurance activities to ensure trial deliverables are achieved.
- Aid in development and maintenance of key project performance indicators and Quality Tolerance Limits for specified metrics.
- Aid Head of Clinical Operations to define and manage trial resource needs.
- Establish succession plans for key resources.
- Act as primary point of sponsor contact for sites and CROs. Escalate issues as needed to appropriate stakeholders.
Skills And Qualifications
- Degree in Life Sciences, nursing or similar qualification(s).
- Oncology experience required.
- Imaging therapy experience required.
- Trial management experience (international preferred) in pharma or CRO industry.
- Knowledge of ICH Guidelines and GCPs.
- Experience managing trials in a virtual environment.
- Site Monitoring experience.
- Clinical Trial document writing experience, including protocol writing.
- Experience of site feasibility and study start up activities.
- Working knowledge of project management processes.
- Good computer skills with good working knowledge of a range of computer programs.
- Eligible to work within the UK.
- Excellent written, verbal, and interpersonal communication skills, as well as a command of English.
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 Miles Tobin at (+1) 617-545-5922 or upload your resume 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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