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Senior Study Manager
Nonclinical Development
Confirmed live in the last 24 hours
Cambridge, MA, USA
Experience Level
  • Bachelor's degree in a scientific-related field with a minimum 10 years of experience in the pharmaceutical, biotechnology, CRO industry
  • Familiarity and working knowledge of a broad range of nonclinical studies relevant to drug development (Toxicology, DMPK, Bioanalytical, Biology, Pharmacology)
  • Familiarity with GLP regulations for the conduct of nonclinical studies to support regulatory filings
  • Demonstrated a team player attitude, ability to work independently in a fast paced, dynamic, and changing environment, takes initiative to identify, analyze and resolve issues
  • Ability to travel to CRO to monitor outsourced studies
  • Experience in working with CROs
  • Excellent communication and presentation skills
  • Point of contact for study communications, activities, and documents from pre-study to study closure (finalization and archiving)
  • Review nonclinical study proposals and ensure that they fulfill all requirements of the program development plan
  • Support vendor quality oversight in partnership with Nonclinical leadership, Nonclinical Development Operations and Quality Operations
  • Manage, communicate, and ensure adhesion to study timelines and milestones
  • In partnership with the Beam scientists, contribute to the study design, and regulatory submissions (as applicable)
  • Work collaboratively with internal and external cross-functional teams or stakeholders
  • Preparation, review, and finalization of nonclinical study documents including protocols, amendments and reports
  • Participate in CRO vendor selection/ due diligence activities
  • Assist in supplier cost and performance at the study level with attention toward opportunities for cost efficiencies
  • Responsible for working with CROs to request slot availability and request quotes for the planned nonclinical studies
  • Communicate and manage study changes and issues; know when and how to escalate issues to management for resolution
  • Monitor the performance of nonclinical studies onsite or remotely at Contract Research Organizations
  • Maintain collaborative relationships and communications between external service providers
  • Ensure compliance with study protocols, GLP regulations (as applicable), and department work instructions
  • Coordinate study samples receiving and archiving
Beam Therapeutics

501-1,000 employees