Senior Manager, Clinical Data Management

The Role:

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:

• Bachelors degree in an analytical or health-related field.

• 6 years of clinical data management experience in industry with experience across indications and relational databases and experience using multiple clinical data management systems.

• Thorough command of FDA and ICH GCP guidelines and industry standards applicable to data capture and data management process to ensure the appropriate conduct of clinical studies.

• 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.

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

• An ability to thrive in a fast-paced innovative environment while remaining flexible proactive resourceful and efficient.

• Creative capable problem-solver.

Pay & Benefits

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.

• Best-in-class healthcare coverage plus voluntary benefit programs to support your unique needs

• A holistic approach to well-being with access to fitness mindfulness and mental health support

• Family planning benefits including fertility adoption and surrogacy support

• Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary year-end shutdown

• Savings and investment opportunities to help you plan for the future

• Location-specific perks and extras

The successful candidate may be eligible for an annual discretionary bonus other incentive compensation or equity award subject to company plan eligibility criteria and individual performance.

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.

If you want to make a difference and join a team that is changing the future of medicine we invite you to visit to learn more about our current opportunities.

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 persons 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 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

Were 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 .

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 applicants 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.

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