Associate, Clinical Trial Operations
$87k/y-$111k/y
BioSpace20 hours ago
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HybridFull-timeEntry
Summary
Insmed is seeking an Associate, Clinical Trial Operations to join their Clinical Operations team in Bridgewater, NJ. The role involves providing operational support for multiple clinical trials and ensuring compliance with relevant regulations and guidelines.
About the Role
As an Associate, Clinical Trial Operations, you will assist in managing clinical trials across all phases, ensuring adherence to study protocols, SOPs, FDA regulations, and ICH/GCP guidelines. Your responsibilities will include maintaining the Trial Master File, conducting quality control checks, coordinating with CROs, and participating in clinical study team meetings.
About You
Required:
- Bachelor's degree in a relevant field.
- Minimum of 2+ years of experience in the pharmaceutical and/or biotechnology industry, specifically in clinical research.
Preferred:
- Basic knowledge of Good Clinical Practice (GCP) and ICH guidelines.
- Experience with Trial Master File (TMF), both paper and electronic (eTMF).
- Strong verbal communication and writing skills.
Benefits
- Comprehensive medical, dental, and vision coverage.
- Generous paid time off policies and flexible work schedules.
- 401(k) plan with competitive company match and annual equity awards.
- Access to the Company Learning Institute for skill development and mentorship.
- Employee resource groups and volunteer opportunities.
BioSpace
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Bridgewater, NJ