Senior Manager, Clinical Data Operations

4 days ago


Princeton, New Jersey, United States Moderna Therapeutics Full time
About the Role

Moderna Therapeutics is seeking a highly skilled Senior Manager, Clinical Data Operations to lead our clinical data management efforts. As a key member of our team, you will be responsible for overseeing the design, development, and implementation of data capture tools and integrations, as well as ensuring compliance with regulatory requirements.

Key Responsibilities
  • Lead clinical data management efforts and initiatives for assigned therapeutic areas
  • Support the oversight of data management vendors and data handling
  • Represent the data management function for clinical studies within assigned therapeutic areas or programs
  • Coordinate with cross-functional team members to ensure achievement of data management deliverables and milestones
  • Design, develop, and implement data capture tools and integrations
  • Ensure compliance with regulatory requirements
  • Manage clinical trial data through review, cleaning, auditing, and validation procedures
  • Review data analysis listings and report on performance and quality
  • Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents
Requirements
  • Bachelor's degree in Biotechnology or related field
  • 6 years of progressive, post-baccalaureate experience in clinical data management or related field
  • Experience with Electronic Data Capture (EDC) systems, Case Report Form (CRF) design, SAS programming, CDISC and STDM standards, Phase 1-3 clinical development
What We Offer
  • Comprehensive and innovative suite of benefits
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • Lifestyle Spending Account funds for personal enrichment and self-care activities
  • Family care benefits, including subsidized back-up care options and on-demand tutoring
  • Generous paid time off, including vacation, sick time, and holidays
  • Discretionary year-end shutdown
  • Paid sabbatical after 5 years; every 3 years thereafter
  • 401k match and Financial Planning tools
  • Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options


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