Research Associate, Gene Therapy
Insmed
PTC Therapeutics seeks a Senior Manager, Clinical Operations to oversee the operational execution of Phase I-IV clinical trials and ensure regulatory compliance. This role manages study timelines, vendor oversight, and cross-functional collaboration while potentially supervising junior team members.
Responsibilities
- Lead or support operational execution of Phase I-IV clinical trials with responsibility for timelines, strategy, and deliverables
- Provide oversight of clinical CROs and service providers to ensure contract compliance and service quality
- Ensure clinical trials comply with ICH-GCP guidelines, regulatory requirements, company SOPs, and study protocols
- Manage site identification, selection, and activation; review monitoring reports and study metrics
- Develop and manage clinical trial management plans, study timelines, vendor scopes, and operational budgets
Requirements
- Bachelor's degree in scientific discipline plus 7+ years clinical research experience in pharma/biotech/CRO
- Strong knowledge of ICH-GCP guidelines and global clinical trial regulations
- Demonstrated ability to lead clinical trial operations and cross-functional teams
- Experience with risk-based quality management and vendor oversight models
- Project management and organizational skills with analytical and problem-solving abilities
- Microsoft Office Suite proficiency
- Experience managing, coaching, and mentoring direct reports (if applicable)
Vacancy posted 6 days ago
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