Manager, RWE Study Operations

The Role:The Manager, RWE Study Operations provides operational leadership for multiple Real-World Evidence (RWE) studies and coordinates cross-functional teams to ensure successful study execution and delivery. This role requires strong project management, vendor oversight, organizational, and problem-solving skills in a fast-paced environment. This position will work with a variety of internal and external team members including research partners, vendors and sites. The position may report to the Director of RWE Study Operations (or above). This role will work across multiple studies to support study management operations activities. The types of studies to be managed in the RWE Study Operations team include but are not limited to Post Authorization Safety Studies (PASS), Post Market Surveillance (PMS) safety studies, Registry Studies, Epidemiological studies, Real World Evidence (RWE) Effectiveness studies, other RWE studies, Integrated Evidence studies and collaborative studies.Here’s What You’ll Do:Perform day-to-day operational project management and oversight of assigned RWE studies to ensure deliverables are met for all assigned studies. Role may include ~6-10 studies across different programs depending on study complexity.Coordinate and lead the cross-functional study team as well as provide backup study management support as needed to other team members.Initiate and lead the vendor outsourcing/contracting activities, if applicable, in collaboration with the study Scientific Lead, Outsourcing, Legal, and Procurement team members and other team members as applicable.Oversee vendor or research partner performance throughout the study lifecycle to ensure quality, timeline, budget, and contractual deliverables are met.Develop and maintain study management documentation, including the Project Management Plan templateCommunicate study status, timelines, budget, and issues to key stakeholders to ensure timely decision making by management.Develop, maintain, and communicate study timelines in collaboration with the Scientific Lead (SL) and key stakeholders.Create, oversee, and/or organize internal team reviews of study documentation and reports.Implement and ensure management of the Trial Master File, if required.Review and provide operational input into protocols, study plans, regulatory documents, publications, study reports, and other study documentation.Oversee biomarker sample tracking and chain of custody, when applicable, to support timely laboratory analysis and study deliverables.Complete and maintain study metrics in trackers and other internal tools including MOST, study team lists, action decision logs, etc.Ensure studies are conducted in accordance with Moderna SOPs and policies and appropriate GxP requirements, Good Pharmacoepidemiology Practices (GPP), and applicable regulatory guidelines.Support user acceptance testing (UAT) of study systems and databases, as applicable.Manage study contracts including review/approval and tracking of invoices, budget management, forecasting and accrual activities.Participate in workstreams related to departmental and operating model improvement initiatives.Develop and maintain strong, collaborative relationships with key stakeholders within and external to Moderna.Identify opportunities to improve operational processes, study execution, and RWE operating models.Identify, document, and manage study-level risks, including maintaining a risk log and coordinating periodic risk reviews with the Study Team, as applicable.Collaborate with Clinical Trial Transparency & Disclosure (CTTD) and Regulatory teams to support study registration, disclosure, and regulatory submissions, as applicable.Oversee data transfer activities and specifications (DTS), ensuring data quality, integrity, and compliance with study protocol and data privacy requirements.Lead study closure activities, ensuring completion of regulatory, financial, and documentation requirements in alignment with study closeout checklists.Here’s What You’ll Bring to the Table:4+ years of experience in a clinical research and industry environment, including a minimum of 2+ years of independent study or project management at a sponsor-company preferredBachelor’s degree required; Advanced degree preferredRelevant experience in observational research, experience in trial management or program management across more than one phase of development, and across entire lifecycle of a study preferredUnderstanding of clinical drug development and the role of Real-World Evidence across the product lifecycle.Strong project management, planning, and organizational skills.Familiarity with AI-enabled productivity tools (e.g., ChatGPT, Microsoft Copilot) and the ability to leverage digital technologies to improve operational efficiency.Demonstrated experience managing CROs, vendors/research partners, contracts, budgets, and operational performance.Critical thinker and problem solver with good organizational skillsAbility to work with urgency and prioritize across multiple studiesWorking knowledge of FDA and ICH GCP, GPP, and applicable regulatory guidance.Excellent verbal and written communication skillsOur 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.Pay & BenefitsAt Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.Competitive healthcare, plus voluntary benefit programs to support your unique needsA holistic approach to well-being, with access to fitness, mindfulness, and mental health supportFamily planning benefits, including fertility, adoption, and surrogacy supportGenerous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownSavings and investments to help you plan for the futureLocation-specific perks and extrasThe salary range for this role is $109,200.00 - $174,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within 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 ModernaSince 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 modernatx.com/careers to learn more about our current opportunities. Equal OpportunitiesModerna 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. AccommodationsWe’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 View email address on click.appcast.io. 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. -SummaryLocation: Cambridge, Massachusetts; Clinical Development; Bethesda, MarylandType: Full time