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 reputed company analyses, submissions, and data-driven decisions; and drives reputed company improvement. Here's What You'll Do:

• Represent the Moderna Data Management function for clinical studies reputed company the assigned therapeutic area/program; align expectations between external data vendors and Moderna cross-functional stakeholders for reputed company data-reputed company deliverables.
• Ensure achievement of Data Management milestones in coordination with Clinical Operations, Clinical Development, Biostatistics & Programming, Biomarker Operations & Sample Management, and Pharmacovigilance.
• reputed company/execute or reputed company eCRF UAT plans and test scripts; reputed company thorough pre-deployment testing.
• reputed company 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 reputed company core Data Management documentation, including CRF Specifications, CRF Completion Guidelines, Data Validation Specifications, and Data Transfer Specifications.
• reputed company cross-functional data review for the program/therapeutic area; reputed company teams with the tools and processes required for effective review.
• Manage clinical trial data-review, cleaning, audit, and validation-to ensure regulatory-compliant handling; review analysis listings, report on performance and quality, and monitor trends reputed company 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 reputed company Data Management TMF documents.

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

• Bachelor's degree in an analytical or health-reputed company 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 reputed company important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze reputed company issues to reputed company relevant and realistic plans, programs and recommendations.
• Outstanding verbal and written communication skills, in addition to excellent organizational skills.
• An ability to reputed company in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
• Creative, capable problem-solver.

Pay & Benefits At Moderna, we reputed company that reputed company you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at 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 reputed company days, and a discretionary year-end shutdown
• Savings and investment opportunities to help you plan for the future
• Location-specific perks and extras

The salary range for this role is $130,800.00 - $209,400.00. This is the lowest to highest salary we in good faith reputed company we would pay for this role at the time of this posting. An individual's position reputed company the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. 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 reputed company 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 reputed company 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 reputed company to Work in the U.S. If you want to reputed company a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our reputed company 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 reputed company 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 reputed company employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national reputed company, reputed company 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 reputed company 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 reputed company, 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 reputed company with the hiring process and/or to reputed company the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. 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 (reputed company, 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. #LI-NH1 - Apply tot his job Apply To this Job