3h ago
Senior Manager, Clinical Scientist, Respiratory
Watertown, MA
full-timeseniorbiotechnology
Description
You will contribute to the execution of clinical trial protocols in Respiratory, working closely with the Clinical Science Study Lead to support high-quality study conduct. You'll perform ongoing clinical data review and monitoring, contribute to study document development, and collaborate across multiple departments to drive clinical development programs forward.
Requirements
- Bachelor's or advanced degree in Life Sciences or related field
- 2+ years in pharmaceutical clinical drug development with global trial experience
- Experience in immunological diseases (e.g., asthma) is a plus
- In-depth understanding of clinical development processes and regulatory guidelines (FDA, EMEA, ICH, GCP)
- Strong critical-thinking, problem-solving abilities and excellent medical writing skills
Responsibilities
- Support day-to-day study activities in collaboration with Clinical Operations
- Conduct ongoing clinical data review and cleaning to ensure data quality and patient safety
- Perform medical data monitoring and partner with Data Management to resolve queries
- Contribute to development and review of study-related documents (protocols, amendments, reports)
- Collaborate with medical directors, regulatory affairs, and other departments in matrix environment
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