Sr. Clinical Trial Manager
Stratacuity Staffing Partners Inc.
Our Burlington based, rapidly growing clinical-stage biotechnology client is seeking an experienced Senior Clinical Trial Manager (Sr. CTM) to lead the operational execution of Phase II and Phase III clinical studies across multiple development programs. This individual will serve as the operational lead for assigned trials, overseeing study conduct from startup through closeout while ensuring timelines, quality, regulatory compliance, and budget objectives are met.
Key Responsibilities:
- Lead the day-to-day management of Phase II/III clinical trials from startup through database lock and study closeout.
- Develop and maintain study timelines, enrollment forecasts, risk management plans, and operational metrics.
- Drive CRO and vendor oversight, performance management, and delivery against study milestones.
- Partner cross-functionally with Clinical Development, Medical Monitoring, Data Management, Biostatistics, Regulatory Affairs, Pharmacovigilance, Clinical Supply, and Quality teams.
- Support site selection, activation, enrollment, retention, and closeout activities.
- Monitor study progress, data quality, protocol compliance, and key performance indicators.
- Ensure adherence to ICH-GCP, FDA regulations, company SOPs, and global clinical trial standards.
- Contribute to study budgets, forecasting, vendor payments, and financial tracking.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field.
- 8+ years of clinical research experience, including 3+ years in a Clinical Trial Manager or comparable leadership role.
- Experience managing Phase II and/or Phase III studies within biotech or pharmaceutical environments.
- Strong CRO and vendor management experience.
- Deep understanding of ICH-GCP, FDA regulations, and global clinical operations.
- Demonstrated ability to lead cross-functional teams and manage multiple priorities in a fast-paced environment.
Preferred Experience:
- Advanced degree (MS, MPH, PharmD, or equivalent).
- Therapeutic area experience in rare disease, endocrinology, metabolic disease, or related fields.
- Experience supporting NDA/BLA-enabling studies.
- Background working in a high-growth biotechnology company.
Vacancy posted 3 days ago
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