Clinical Trial Manager (Med Device)
Clinical Trial Manager (Med Device)
Stellent IT
Boston, MA
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About The Job
Our client is a globally-distinguished medical device manufacturer who specializes in the development and commercialization of innovative medical devices to improve patient lives around the world. Our client needs a Clinical Trial Manager (CTM) Consultant who will be responsible for leading cross-functional clinical teams in the design, planning, and execution of clinical studies in support of the global business objectives for product development and/or commercialization.
This is a 12 month assignment for the site in Marlborough, MA. The ability to be onsite 1 day/week is highly preferred, but not required.
Assignment Overview
Our client is a globally-distinguished medical device manufacturer who specializes in the development and commercialization of innovative medical devices to improve patient lives around the world. Our client needs a Clinical Trial Manager (CTM) Consultant who will be responsible for leading cross-functional clinical teams in the design, planning, and execution of clinical studies in support of the global business objectives for product development and/or commercialization.
This is a 12 month assignment for the site in Marlborough, MA. The ability to be onsite 1 day/week is highly preferred, but not required.
Assignment Overview
- Lead and drive the project team in the planning, execution and management of all operational aspects of clinical trials.
- Leads, direct, and execute worldwide clinical studies and/or programs, including first in human studies, in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures.
- Track development of and collaborate with the project team on all internal and external project materials, processes, manuals, plans, committees, study systems and all sponsor required regulatory submissions.
- Interact and collaborate with physicians from diverse specialties
- Ensure the project team maintains a continuous state of audit readiness.
- Lead the proactive identification, assessment, and management of clinical study risks.
- Inform and present study progress and known risks to Senior Leadership.
- Provide clinical input to product development activities.
- Technical Requirements:BS Degree Minimum, Advanced degree preferred
- 8+ years of clinical research experience
- Cardiovascular device clinical trial experience highly preferred
- Intimate knowledge of GCP, ISO 14155, and FDA regulations governing the conduct of clinical trials
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Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Other -
Industries
IT Services and IT Consulting
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