Senior Manager, Clinical Data Management

Role Description

Moderna Services, Inc. seeks a Sr. Manager, Clinical Data Management for its Cambridge, Massachusetts location.

Here’s What You’ll Do:

• 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
  • 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.

Qualifications

• Requires a Bachelor’s degree, or foreign equivalent, in Biotechnology, Biology, Biological Sciences, or related field.
• 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
  • Medidata 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
  • SDTM and CDISC datasets, Clinical Data Studio, SQL & SAS

Requirements

• 100% telecommuting permitted from anywhere within the US.

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.