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.