Sr. Manager, Clinical Data Management

The Role:  Moderna Services, Inc. seeks a Sr. Manager, Clinical Data Management for its Princeton, New Jersey location.

Here’s What You’ll Do:

• Lead clinical data management efforts and initiatives for an assigned therapeutic area. Support the oversight of data management vendors and data handling.

• Represent the data management function for clinical studies within the assigned therapeutic area or program and ensure aligned expectations between external data vendors and internal cross-functional stakeholders for all data related deliverables.

• Coordinate with cross functional team members including Clinical Operations, Clinical Development, Biostatistics & Programming, Biomarker Operations & Sample Management and Pharmacovigilance to ensure achievement of data management deliverables and milestones.

• Lead and oversee the design, creating and testing and implementation of data capture tools and integrations for data capture, data processing, coding and validation in accordance with the data collection requirements as defined in the clinical protocol, in alignment with industry best practice guidelines, including CDISC and STDM standards.

• Author or oversee the development of all Data Management documentation including CRF Specifications, CRF Completion Guidelines, Data Validation Specifications, and Data Transfer Specifications.

• Lead the cross-functional data review for the assigned program or therapeutic area; support cross-functional team with tools and processes to successfully enable and achieve cross-functional data review.

• Manage clinical trial data through review, cleaning, auditing, validation procedures and ensure data handling in compliance with regulatory requirements.

• Review data analysis listings and report on performance and quality; review clinical data within and across studies for trend analysis.

• Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.

• May telecommute up to 2 days per week.

Here’s What You’ll Bring to the Table:

• Requires a Bachelor’s degree in Biotechnology or related field and 6 years of progressive, post-baccalaureate experience in the position offered or as a Clinical Database Manager/Analyst or related position. In the alternative, employer will accept a Master’s degree in the stated fields and 4 years of experience in the stated occupations.

• Must have 4 years of experience with: Electronic Data Capture (EDC) systems; Case Report Form (CRF) design; SAS programming; CDISC and STDM standards; Phase 1-3 clinical development; Devising plans for operational challenges including data review in dose escalation, vendor oversight, protocol deviation management, and data cleaning.

• May telecommute up to 2 days per week.

Apply at https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx (Job ID: R16755 or email resume and cover letter to careers@modernatx.com with subject line: R16755).

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!