Clinical Trial Manager/ Senior Clinical Trial Manager
New
Based in the United StatesFull-TimeSenior
SalaryCompetitive salary range of approximately $110,700 to $200,900 USD, depending on experience and location
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Job Details
- Experience
- Minimum of 7+ years of clinical research experience
- Required Skills
- Project ManagementMicrosoft OfficeRisk Management
Requirements
- Bachelor’s degree in life sciences, health-related field, or equivalent clinical research experience.
- Minimum of 7+ years of clinical research experience with significant trial management or monitoring exposure.
- Strong knowledge of ICH-GCP guidelines and regulatory requirements.
- Proven ability to lead cross-functional teams and manage complex clinical studies.
- Experience with clinical trial planning, risk management, and vendor/stakeholder coordination.
- Strong leadership skills with ability to guide teams and delegate effectively.
- Proficiency with standard office tools (Excel, Word, PowerPoint, Outlook) and clinical trial management systems.
- Ability to travel domestically and internationally as required.
Responsibilities
- Serve as the primary operational lead for assigned clinical trials, overseeing planning, execution, and close-out activities.
- Act as the main point of contact for clients, investigators, and cross-functional study stakeholders.
- Develop and maintain key clinical study documents including protocols, informed consent forms, monitoring plans, and study trackers.
- Lead site feasibility, selection, and recruitment strategy development to support enrollment targets.
- Oversee study start-up activities including submissions to IRBs and regulatory authorities.
- Coordinate cross-functional collaboration with CRAs, data management, programming, QA, and vendors.
- Monitor study performance using metrics, proactively identifying risks and implementing corrective actions.
- Oversee investigational product (IP) management, drug accountability, and reconciliation processes.
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