Senior Clinical Trial Manager managing global Phase 3 clinical trials for oncology at Verastem Oncology. Overseeing vendor management, budget adherence, and regulatory compliance throughout the project lifecycle.
About the role
- Senior Manager overseeing clinical studies and drug development programs at Regeneron. Collaborating with cross-functional teams to ensure data integrity and compliance with clinical guidelines.
Responsibilities
- Leads in the development, evaluation, planning and execution of clinical studies
- Ensures integrity and interpretation of study data of a clinical development program
- Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings
- Applies basic scientific expertise to support initiation and execution of clinical research and development studies
- Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
- Exhibits strong analytical knowledge and skills to understand how study objectives and design impact data analysis
Requirements
- Bachelor’s Degree; Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc)
- ≥ 8 years of pharmaceutical clinical drug development experience
- Proven knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology & medical writing skills
- Knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines
- Proven track in clinical trial process improvements
- Considerable organizational awareness, including significant experience working cross-functionally
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)
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