Associate Director, Clinical Data Management, Infectious Disease

About the position Moderna Services, Inc. seeks an Associate Director, Clinical Data Mgmt, Infectious Disease for its Princeton, New Jersey location. This role will lead clinical data management efforts and initiatives for the Infectious Disease Therapeutic Area and support oversight of data management vendors and data handling. The Associate Director will represent the data management function for Infectious Disease trials and ensure aligned expectations between external data vendors and Moderna cross-functional stakeholders for all data related deliverables. They will ensure Electronic Data Capture systems are built correctly to reflect protocol requirements and oversee data vendor activities including consistency, quality, and timeliness of all deliverables across Infectious Disease in compliance with GCP, SOP, and regulatory requirements. The role ensures achievement of data management deliverables and milestones in coordination with cross-functional team members including Clinical Operations, Clinical Development, Biostatistics & Programming, Biomarker Operations & Sample Management, and Pharmacovigilance. The Associate Director will lead the design, creation, testing, and implementation of data capture tools and integrations for data capture, data processing, medical coding, and validation in accordance with data collection requirements as defined in the clinical protocol, in alignment with industry best practice guidelines and enforcement of Moderna data standards and processes. They will author and oversee the development of all Clinical Data Management documentation including CRF Specifications, CRF Completion Guidelines, Data Validation Specifications, and Data Transfer Specifications. The role involves leading the cross-functional data review for the Infectious Disease program, and supporting the cross-functional team with tools and processes to successfully enable and achieve cross-functional data review. The Associate Director will manage clinical trial data through review, cleaning, auditing, and validation procedures and ensure data handling compliance with regulatory requirements. They will lead and participate in clinical data review and report on performance and quality, review clinical data within studies and across for trend analysis, and lead cross-functional data review meetings including internal and external study team members, ensuring alignment of data delivery strategy for Infectious Disease trials. The role also ensures archival and inspection readiness of all Data Management Trial Master File (TMF) documents for Infectious Disease trials and ensures inspection readiness for data management. Additionally, the Associate Director will contribute to Moderna Data Management Initiatives and Innovation Implementation and participate in the development and optimization of data management SOPs, processes, and initiatives.

Responsibilities

• Lead clinical data management efforts and initiatives for the Infectious Disease Therapeutic Area and support oversight of data management vendors and data handling.
• Represent the data management function for Infectious Disease trials and ensure aligned expectations between external data vendors and the Moderna cross-functional stakeholders for all data related deliverables.
• Ensure Electronic Data Capture system is built correctly to reflect the protocol requirements.
• Data vendor oversight activities including consistency, quality and timeliness of all deliverables across Infectious Disease in compliance with GCP, SOP and regulatory requirements.
• Ensure achievement of data management deliverables and milestones in coordination with cross functional team members including Clinical Operations, Clinical Development, Biostatistics & Programming, Biomarker Operations & Sample Management, and Pharmacovigilance.
• Lead the design, creation and testing and implementation of data capture tools and integrations for data capture, data processing, medical coding and validation in accordance with the data collection requirements as defined in the clinical protocol, in alignment with industry best practice guidelines and enforcement of Moderna data standards and processes.
• Author and oversee the development of all Clinical Data Management documentation including CRF Specifications, CRF Completion Guidelines, Data Validation Specifications, and Data Transfer Specifications.
• Lead the cross-functional data review for the Infectious Disease program, and support cross-functional team with tools and processes to successfully enable and achieve cross-functional data review.
• Manage clinical trial data through review, cleaning, auditing, validation procedures and ensure data handling compliance with regulatory requirements.
• Lead and participate in clinical data review and report on performance and quality.
• Review clinical data within studies and across for trend analysis.
• Lead cross-functional data review meetings including internal and external study team members; and ensure alignment of data delivery strategy for Infectious Disease trials.
• Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents for Infectious Disease trials and ensure inspection readiness for data management.
• Contribute to Moderna Data Management Initiatives and Innovation Implementation.
• Participate in the development and optimization of data management SOPs, processes, and initiatives.

Requirements

• Minimum of a Bachelor’s degree, or foreign equivalent, in Pharmaceutical Science, Public Health, Biology, or related field
• Seven (7) years of progressive, postbaccalaureate experience as a Senior Manager of Clinical Data Management, Clinical Data Manager, Clinical Data Analyst, or related position involving clinical data management.
• Seven (7) years of experience must include: Electronic Data Capture System development and testing
• Applying understanding of Clinical Data Interchange Standards Consortium (CDISC) and SDTM standards
• Phase I-IV clinical development
• Applying knowledge of FDA & International Council for Harmonization regulations for data capture and data management processes
• Building and testing clinical study databases including Rave and integrating databases with Safety Gateway & Rave coder
• Utilizing Rave Modules, J Review, and Elluminate to run clinical study listings

Benefits

• Best-in-class healthcare coverage
• Voluntary benefit programs
• 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
• Location-specific perks and extras
• Annual discretionary bonus, other incentive compensation, or equity award (subject to eligibility and performance)