- Lead daytoday Clinical Operations activities for a clinical trial, including startup, maintenance, and closure.
- Manage compliance and quality of a clinical trial, including maintaining accurate documentation of trial progress.
- Define and execute quality control steps, including study quality and performance metrics and reporting.
- Coordinate data review activities required of Clinical Operations team members.
- Contribute to the development of study protocols and understand study protocol objectives.
- Lead development of clinical trialrelated documents, including approving and maintaining study plans.
- Conduct study feasibility and ensure proper site selection and setup.
- Manage and drive processes for outsourcing to CROs and other thirdparty vendors
- Bachelor's degree in life sciences required; master's degree preferred.
- Relevant clinical operations experience with a focus on trial management.
- Excellent understanding and application of ICH/GCP guidelines.
- Strong interpersonal and communication skills.
- Ability to travel up to 25%.
- Proactive, organized, with attention to detail and excellent problemsolving skills.
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Clinical Trial Manager
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Fusion Pharmaceuticals LLC Chelsea, United StatesFusion Pharmaceuticals (NASDAQ: FUSN) · is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitti ...
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Fusion Pharmaceuticals LLC Everett, United StatesFusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting ...
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Stratacuity Cambridge, United StatesLocation: Cambridge, MA (Hybrid) · Science: Antibody Drug Conjugates · Therapeutic Area: Oncology · Job Overview: This role is an exciting opportunity for a motivated individual to strategically guide the operationalization of our clients clinical strategy, mentor colleagues, ...
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Vor Biopharma Inc. Cambridge, United StatesWho we are looking for: · Vor Bio is seeking a Senior Clinical Trial Manager to join our dynamic Clinical Operations team. The Senior Clinical Trial Manager (Sr CTM) is a motivated, independent, organized individual who will be responsible for the successful execution of clinical ...
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BioSpace Cambridge, United StatesJob Details · The Role · The Senior Clinical Trial Manager (Sr. CTM) provides clinical trial oversight to the assigned clinical trial(s), which may be complex or high priority, and ensures deliverables are met in terms of quality, compliance and timing.Strong vendor management is ...
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Bicycle Therapeutics Cambridge, United StatesJob Description · Job DescriptionCompany Description · Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell a ...
Sr. Clinical Trial Manager - Boston, MA, United States - ProClinical
Description
Proclinical is seeking a dedicated Senior Clinical Trial Manager (CTM) to join our global Clinical Operations Department.The successful candidate will play a crucial role in managing and executing clinical trials, ensuring compliance with regulations, maintaining timelines, and overseeing data collection and review.
The Senior CTM will also be responsible for managing the Clinical Operations study team, Clinical Research Organizations (CROs), and third-party vendors.
Responsibilities:
Key Skills and Requirements:
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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