Study Manager
New
US based remote positionContractManager
Salary not disclosed
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Job Details
- Experience
- 7+ years of clinical operations experience
- Required Skills
- Data management
Requirements
- BA/BS degree
- 7+ years of clinical operations experience
- Direct experience in unblinded or partially blinded study management
- Working knowledge of ICH/GCP and regulatory expectations
- Experience in drug development, trial design, and planning
- Proven CRO and vendor oversight experience
- Effective cross-functional communication skills
- Ability to work independently in a contract capacity
- Experience with EU-CTR is a plus
Responsibilities
- Serve as the unblinded operational lead for assigned clinical studies
- Support and manage study activities including CROs and vendor oversight
- Oversee study documentation such as plans, logs, and trackers
- Support data review and issue resolution with Data Management and Safety teams
- Maintain firewalls between blinded and unblinded personnel
- Provide unblinded operational updates to stakeholders
- Contribute to inspection readiness and support regulatory requests
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