Senior Manager, Clinical Data Management

Senior Manager, Clinical Data Management

The Senior Manager, Clinical Data Management leads end-to-end clinical data management across assigned studies / programs, establishing best-in-class standards and processes, optimizing systems, and overseeing CRO / vendor execution. Partners with Biostatistics, Clinical Operations, Safety, and Regulatory to deliver timely, compliant, inspection-ready, high-quality data that enable analyses, submissions, and data-driven decisions; and drives continuous improvement.

Heres What Youll Do :

• Represent the Moderna Data Management function for clinical studies within the assigned therapeutic area / program; align expectations between external data vendors and Moderna cross-functional stakeholders for all data-related deliverables.
• Ensure achievement of Data Management milestones in coordination with Clinical Operations, Clinical Development, Biostatistics & Programming, Biomarker Operations & Sample Management, and Pharmacovigilance.
• Develop / execute or oversee eCRF UAT plans and test scripts; perform thorough pre-deployment testing.
• Lead the design, creation, testing, and implementation of data-capture tools and integrations for capture, processing, coding, and validation, per protocol requirements and industry best practices.
• Author or oversee core Data Management documentation, including CRF Specifications, CRF Completion Guidelines, Data Validation Specifications, and Data Transfer Specifications.
• Lead cross-functional data review for the program / therapeutic area; equip teams with the tools and processes required for effective review.
• Manage clinical trial datareview, cleaning, audit, and validationto ensure regulatory-compliant handling; review analysis listings, report on performance and quality, and monitor trends within and across studies.
• Collaborate with the Data Standards Committee as a liaison among study team members to standardize data collection and reporting.
• Ensure archival and inspection-readiness of all Data Management TMF documents.

Heres What Youll Bring To The Table :

At Moderna, we believe that when you feel your best, you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work, at home, and everywhere in between.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

Our Working Model

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70 / 30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and / or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com.

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.