Clinical Trials Senior Project Manager
New
R
Rochester Regional HealthClinical trials
Remote, United StatesFull-TimeSenior
Salary100,000 - 125,000 USD per year
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Job Details
- Experience
- 3 years project management experience; 1 years’ experience in clinical trials, laboratory or healthcare setting
- Required Skills
- GCPProblem Solving
Requirements
- Have 3 years of project management experience.
- Have 1 year of experience in clinical trials, a laboratory, or a healthcare setting.
- Be able to manage protocols regardless of the geographic coverage of site selection.
- Have working knowledge of FDA, NYSDOH, GCP, ICH, and other regulations relevant to central laboratory functions.
- Be able to travel overnight for investigator training, client events, and ACM international locations.
- Be able to provide on-call coverage as assigned.
- A master’s degree is preferred.
- Excellent problem-solving and communication skills are preferred.
Responsibilities
- Serve as the client’s primary point of contact for laboratory aspects of clinical trials.
- Manage assigned protocols from study setup through maintenance and closeout.
- Coordinate internally and with regional Project Managers to ensure trials follow the Global Laboratory Specification Document.
- Oversee the output of assigned regional Project Managers and mentor junior department and team members.
- Review clinical protocols and assist with protocol setup.
- Develop Global Laboratory Specification Documents, Investigator Manuals, and protocol-specific Global Work Practice Instructions.
- Participate in and document clinical-trial quality audits and inspections.
- Review monthly project metrics, trial activity, and budgets.
- Conduct investigator training by telephone or at investigator meetings.
- Maintain regulatory-required study documentation and develop protocol-specific procedures as needed.
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