Sr. Manager, Clinical Data Management, Infectious Disease

The Role:

Moderna is seeking a Senior Manager, Clinical Data Management, Infectious Disease to lead clinical data management efforts and initiatives for the Infectious Disease Therapeutic Area as well as support the oversight of data management vendors and data handling. This role will report to the Director, Clinical Data Management at Moderna

Here’s What You’ll Do:

• Represents the Moderna data management function for clinical studies within a Therapeutic Area or program and ensures aligned expectations between external data vendors and the Moderna cross-functional stakeholders for all data related deliverables

• Ensures achievement of data management deliverables and milestones in coordination with cross functional team members including: Clinical Operations, Clinical Development, Biostatistics & Programming, Biomarker Operations & Sample Management and Pharmacovigilance

• Responsible for leading/overseeing 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;

• Responsible for authoring or overseeing the development of all Data Management documentation including CRF Specifications, CRF Completion Guidelines, Data Validation Specifications, Data Transfer Specifications; etc.

• Responsible for leading the cross-functional data review for a 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 compliance with regulatory requirements; Review data analysis listings and report on performance and quality; review clinical data within studies and across for trend analysis

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

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

• Bachelor’s Degree in an analytical or health-related field

• 8+ years of clinical data management experience in industry, with experience across indications and relational databases and experience using multiple clinical data management systems

• Phase 1-3 clinical development experience

• Multi-faceted background devising plans for operational challenges such as site EDC training, preparing cohorts for data review in dose escalation, vendor oversight, protocol deviation management, data cleaning, etc.

• Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations

• Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process

• Outstanding verbal and written communication skills, in addition to excellent organizational skills

• Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient

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!

About Moderna

Since our founding in 2010, we have aspi