Senior Clinical Trial Manager
New
Australia, Austria, Canada, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom, United StatesFull-TimeSenior
Salary130,000 - 160,000 USD per year
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Job Details
- Experience
- 6+ years
- Required Skills
- Project Management
Requirements
- BS/BA degree in a relevant scientific discipline.
- 6+ years of relevant industry experience in clinical drug development.
- Minimum 3 years of experience as a Clinical Research Associate (CRA).
- Minimum 2 years of experience in clinical study management.
- Strong knowledge of protocol, clinical study design, and monitoring processes.
- Demonstrated experience in the management of CROs and external vendors.
- Working knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCP.
- Experience leading global clinical research activities.
- Advanced project management, cross-functional team leadership, and organizational skills.
- Proficiency with MS Word, PowerPoint, Excel, and Project Management software.
Responsibilities
- Lead the cross-functional Study Management Team (SMT) to ensure objectives of the Clinical Development Plan (CDP) are met.
- Oversee the identification, selection, on-boarding, and management of study vendors including CROs and specialty labs.
- Act as the main point of contact for Full-service CROs and manage all sub-contracted activities.
- Provide study-specific training and oversight to vendor personnel to ensure delivery per the scope of work.
- Oversee internal and external stakeholders to ensure clinical trial data is appropriately captured, monitored, and quality-assured.
- Review and approve study management plans and documentation including budgets, accruals, and monitoring reports.
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