Sr. Manager, Clinical Data Management

Moderna • Cambridge, MA

2d • $130,800 - $209,400 • Remote

About The Position

Moderna Services, Inc. seeks a Sr. Manager, Clinical Data Management for its Cambridge, Massachusetts location. This role involves leading data management activities for in-house and outsourced studies, including vendor oversight across global development programs. The Sr. Manager will represent the data management function in clinical cross-functional meetings, ensuring aligned expectations with Contract Research Organizations (CROs) for all data-related deliverables, particularly for key decision points and regulatory submissions. The position requires ensuring milestones and deliverables are met with high quality, partnering with stakeholders and CROs to mitigate risks, and providing input to functional governance with Moderna's strategic suppliers. The role also involves resolving escalated issues from vendors or cross-functional teams, leading clinical trial data collection setup, data review, and database lock for studies managed internally by Moderna. This includes working with other functions to set up Electronic Data Capture (EDC) and study data collection tools like Interactive Response Technology (IRT), ePRO, and eCOA. The Sr. Manager will lead the creation and maintenance of study cross-functional data review plan components, such as edit checks, listing review checks, data integration specifications, data transfer specifications, external data reconciliation plans, coding guidelines, SAE reconciliation guidelines, and database lock plans. Responsibilities also include leading data review, query management, and activities for interim and final database locks, ensuring archival and inspection readiness of Data Management Trial Master File (TMF) documents. The role ensures the achievement of major data management deliverables and milestones in coordination with Clinical Operations, Clinical Development, Biostatistics & Programming, Biomarker Operations & Sample Management, and Pharmacovigilance. Planning and managing external Data Management budgets and timelines for accuracy, understanding variance trends, and supporting continuous improvement in forecasting are also key. The Sr. Manager will act as a process expert for operational and oversight models, maintain Standard Operating Procedures (SOPs), process maps, templates, and timelines. They may prepare metrics for function Key Performance Indicators (KPIs) and represent the function in external professional initiatives (SCDM, CDISC, DIA) to identify industry best practices and enhance Moderna's visibility. Leading functional Continuous Improvement initiatives, providing strategic direction, and identifying key deliverables that meet timelines, budget, and requirements are essential. The role requires cross-functional collaboration to ensure data quality and timely delivery of all data management deliverables. Championing and adopting technology improvements and tools for clinical data management processes, and ensuring compliance with Learning Curricula, corporate, and GXP requirements are also part of the role.

Requirements

• Requires a Bachelor’s degree, or foreign equivalent, in Biotechnology, Biology, Biological Sciences, or related field and 8 years of progressive, post-baccalaureate experience as a Sr. Manager, Assistant Clinical Data Manager, Clinical Data Associate or related position supporting clinical data management for the pharmaceutical industry.
• 7 years of experience must include: Vendor Management; Medias RAVE, InForm, and Oracle Clinical EDC tools; Clinical Data Management using Biomarker and External data; Utilizing eTMF tools; Study Database Lock processes including Final, Interim, Snapshots, DSUR submission, and Staggered Lock; Study Initiation, CSR Review, and SAE Reporting; J-Review, I-Review, and Clinbrowser; and SDTM and CDISC datasets, Clinical Data Studio, SQL & SAS.

Responsibilities

• Lead data management activities for in-house and outsourced studies.
• Responsible for vendor oversight activities across global development programs.
• Represent data management function in clinical cross-functional meetings, ensuring aligned expectations between the Contract Research Organization (CRO) and Moderna for all data related deliverables, especially in support of key decision points and regulatory submissions.
• Ensure established milestones and deliverables are met with the highest degree of quality.
• Partner with appropriate stakeholders and CRO partners to mitigate and resolve risks.
• Provide input to functional governance with Moderna strategic suppliers.
• Partner with appropriate stakeholders to resolve issues escalated from the vendor and/or cross-functional teams.
• Lead and manage clinical trial data collection set-up, data review, and database lock for studies where data management activities are conducted within Moderna.
• Work with other functions to complete set up of Electronic Data Capture (EDC) and study data collection tools such as Inter-response time (IRT), ePRO and eCOA.
• Lead the creation and maintenance of study cross functional data review plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plans, coding guidelines, Serious Adverse Events (SAE) reconciliation guidelines, and database lock plans.
• Lead data review, including query management, and activities required for interim and final database locks.
• Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
• Ensure achievement of major data management deliverables and milestones in coordination with the Clinical Operations Clinical Development, Biostatistics & Programming, Biomarker Operations & Sample Management and Pharmacovigilance.
• Plan and manage external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.
• Act as a process expert for operational and oversight models.
• Maintain Standard Operating Procedures (SOPs), process maps and templates and timelines to support functions operational and oversight models.
• May prepare metrics to support the function Key Performance Indicators (KPIs).
• Represent function in external professional initiatives and organizations such as SCDM, CDISC, and DIA to identify industry best practice and increase the visibility of Moderna.
• Lead functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with requirements.
• Work cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables.
• Champion and adopt technology improvements and tools for use in clinical data management processes.
• Ensure compliance with own Learning Curricula, corporate and GXP requirements.

Benefits

• 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.
• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• Savings and investments to help you plan for the future

What This Job Offers

• Job Type: Full-time
• Career Level: Manager