Centessapharmaceuticalsinc
Clinical Trial Manager (Contract)
Boston, MA. Posted a month ago
The role
This person will lead the execution of mid-to-late stage global clinical studies from start-up through close-out. They will manage day-to-day trial operations, coordinate cross-functional teams, and oversee CROs and external vendors.
What you will do
- Plan and execute mid-to-late stage CNS clinical trials.
- Lead day-to-day clinical trial operations and coordinate cross-functional partners.
- Oversee CROs and external vendors including co-monitoring activities.
- Drive critical study milestones including site activation, enrollment, and database lock.
- Review and approve CRO and vendor generated plans and study documentation.
- Monitor study progress using operational metrics, dashboards, and financial tracking.
- Identify, assess, and manage operational risks.
- Ensure inspection and audit readiness and oversee Trial Master File maintenance.
- Contribute to operational planning and regulatory deliverables.
Required qualifications
- Bachelor’s degree in a scientific or health-related discipline.
- 5+ years clinical trial management experience within an industry sponsor environment.
- Proven ability to manage global clinical studies.
- Strong working knowledge of ICH guidelines, GCP, and global regulatory requirements.
- Solid understanding of project management principles.
- Excellent communication, collaboration, and interpersonal skills.
- Ability to manage multiple priorities in a fast-paced environment.
- Proactive problem-solving mindset.
Nice to have
- Experience managing clinical trials in CNS therapeutic development
- PMP or similar training
Benefits
- Medical plans including PPO and EPO options
- Dental coverage
- Vision coverage
- 401 (k)
- Wellness programs
- Other discounts
About the company
Centessa Pharmaceuticals is a clinical-stage company developing orexin receptor 2 (OX2R) agonists for the treatment of narcolepsy and other sleep-wake disorders. It is a wholly owned subsidiary of Eli Lilly and Company.