Senior Manager, Clinical Data Management, Infectious Disease

The Role: Moderna is looking for a Senior Manager, Clinical Data Management, Infectious Disease to lead clinical data management initiatives for the Infectious Disease Therapeutic Area and support data management vendors and data handling oversight. The role will report to the Director, Clinical Data Management at Moderna. Here’s What You’ll Do: - Represent Moderna's data management function for clinical studies within a Therapeutic Area or program - Ensure the alignment of expectations between external data vendors and the Moderna's cross-functional stakeholders for all data-related deliverables - Coordinate the achievement of data management deliverables and milestones with team members from Clinical Operations, Clinical Development, Biostatistics & Programming, Biomarker Operations & Sample Management, and Pharmacovigilance - Lead design, creation, and testing of data capture tools and integrations for data capture, processing, coding, and validation in accordance with clinical protocol requirements and best practices - Author or oversee the development of all Data Management documentation - Lead the cross-functional data review for a program or therapeutic area - Manage clinical trial data through review, cleaning, auditing, validation procedures, and ensure compliance with regulatory requirements - 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 - Over 8 years of clinical data management experience in the industry, with experience across indications and relational databases - Phase 1-3 clinical development experience - Ability to develop important relationships with key stakeholders, manage conflict, negotiate, and analyze complex issues to develop relevant plans, programs, and recommendations - Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process - Excellent verbal and written communication skills, organizational skills - Flexibility, proactivity, resourcefulness, and efficiency in a fast-paced, innovative environment Moderna offers a comprehensive and innovative suite of benefits, including: - Highly competitive medical, dental and vision coverage options - Flexible Spending Accounts - Lifestyle Spending Account - Family care benefits - Free premium access to fitness, nutrition, and mindfulness classes - Preferred pricing on Peloton fitness equipment - Adoption and family-planning benefits - Generous paid time off (including vacation, sick time, holidays, community volunteer time, year-end shutdown, sabbatical) - 18 weeks of 100% paid parental leave - 401k match and Financial Planning tools - Life, LTD and STD insurance coverages - Complimentary concierge service - Free parking or subsidized commuter passes About Moderna: Since 2010, we aim to build a leading mRNA technology platform, the infrastructure to reimagine medicine creation and delivery, and a world-class team. We provide a platform for our people to contribute to scientific progress and our culture. We have been recognized as a Top Biopharma Employer, a Best Workplace for Innovators, and a Great Place to Work in the U.S. If you're looking to make a difference and join a team changing the future of medicine, we invite you to apply. Moderna is an equal opportunity workplace and affirmative action employer. We are committed to equal employment opportunity and non-discrimination regardless of race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or veteran status, genetic information, sexual orientation, marital or familial status, or any other protected characteristic. We believe in attracting, retaining, developing, and advancing our employees, and providing an environment where every employee can contribute their best. Moderna provides reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation should contact the Talent Acquisition Partner or the Accommodations team at [email protected].