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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