Lead Clinical Trials Manager
6 days ago
Boston Pharmaceuticals is a clinical-stage biopharmaceutical company with a strong focus on developing innovative targeted therapies for serious liver diseases. We are currently seeking an experienced Sr. Clinical Trial Manager to support the management and progression of all our clinical programs.
Key Responsibilities:
- Manage contract research organizations (CROs) and external vendors to ensure compliance with Boston Pharmaceuticals' quality systems.
- Independently manage study activities, including monitoring, performance management, data collection, and reporting.
- Collaborate with cross-functional teams to develop and manage study timelines and budgets.
- Develop and review clinical study documents, including contracts, informed consent forms, and protocol amendments.
Requirements:
- Bachelor's degree in a relevant field and +5 years of experience in direct clinical trial management, including vendor and CRO management.
- Working knowledge of GCP, ICH, and CFR regulations.
- Experience managing late-stage clinical trials.
- Strong project management skills, effective communication, adaptability, and self-motivation.
- Ability to work independently and prioritize multiple tasks efficiently.
- Experience integrating with cross-functional teams, such as regulatory, CMC, procurement, and finance.
- Resourceful and able to handle changing priorities.
Salary Range:$120,000 - $160,000 per year
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