Lead Site Manager
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Job Description
Lead Site Manager overseeing site management for NIH-funded Long COVID clinical trials. Providing operational leadership and supporting a team across multiple clinical trial sites.
Responsibilities:
- Oversee and support site management functions in collaboration with the Site Managing Director.
- Provide day-to-day operational leadership and support for site management team staff.
- Support site identification, feasibility/qualification, start-up, activation, maintenance, and close-out activities.
- Serve as an escalation point for site-related operational challenges.
- Support and coordinate site contracting activities with the contracts and finance team.
- Oversee site management team staff in the collection, review, and maintenance of essential regulatory documents.
- Coordinate with regulatory affairs and central IRB teams.
- Serve as a primary operational interface with key external vendors.
- Support interactions with NIH program staff and external stakeholders related to site operations.
- Monitor site performance metrics and review monitoring trends with the site monitoring CRO.
Requirements:
- Bachelor's Degree and 12 years of experience, Master's degree and 10 years of experience, PhD and 6 years of experience, or equivalent combination of education and experience.
- Experience with NIH-funded or government-sponsored trials.
- Strong knowledge of GCP and regulatory requirements.
- Prior experience as a Lead Site Manager, Lead CRA, or equivalent position title.
- Ability to work in a matrixed environment.
- Legally authorized to work in the United States without requiring sponsorship for employment visa status.
Benefits:
- Health insurance
- 401(k) matching
- Paid time off
- Remote work options
- Financial assistance with adoption expenses or infertility treatments
- Financial reimbursement for education and developmental opportunities
- Employee assistance program
- Merit-based annual increases
- Bonus opportunities
- Generous paid parental leave for all parents
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