Associate Director, Clinical Data Management, Infectious Disease

Role Summary Associate Director, Clinical Data Management, Infectious Disease – Princeton, New Jersey. The role leads data management for Infectious Disease trials, overseeing vendors, ensuring compliance, constructing and validating data capture systems, and coordinating cross‑functional teams. Key Responsibilities Lead clinical data management initiatives for the Infectious Disease Therapeutic Area, including vendor oversight and coordination with cross‑functional stakeholders. Represent the data management function for Infectious Disease trials, ensuring alignment between external vendors and internal stakeholders regarding data deliverables. Ensure the Electronic Data Capture (EDC) system reflects protocol requirements and is built correctly. Oversee data vendor activities for consistency, quality, and timeliness of deliverables, ensuring compliance with GCP, SOPs, and regulatory requirements. Coordinate achievement of data management milestones with Clinical Operations, Clinical Development, Biostatistics & Programming, Biomarker Operations & Sample Management, and Pharmacovigilance. Design, create, test, and implement data capture tools, integrations, medical coding, and validation processes in accordance with clinical protocols and industry best practices. Author and oversee development of Clinical Data Management documentation, including CRF specifications, completion guidelines, validation specifications, and transfer specifications. Lead cross‑functional data reviews and support team tools and processes for successful data review cycles. Manage clinical trial data through review, cleaning, auditing, validation, and ensure regulatory compliance. Participate in data review meetings with internal and external study teams and align data delivery strategy. Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents for Infection Disease trials. Participate in Moderna Data Management initiatives, SOP development, process optimization, and innovation implementation. Minimum Requirements Bachelor’s degree (or foreign equivalent) in Pharmaceutical Science, Public Health, Biology, or a related field. Seven (7) years of progressive, post‑baccalaureate experience as a Senior Manager, Clinical Data Manager, Clinical Data Analyst, or a comparable role involving clinical data management. Experience with Electronic Data Capture system development and testing. Applying knowledge of CDISC and SDTM standards. Experience with Phase I‑IV clinical development. Knowledge of FDA and International Council for Harmonization regulations for data capture and data management processes. Experience building and testing clinical study databases, including Rave, and integrating databases with Safety Gateway & Rave coder. Proficiency with Rave Modules, J Review, and Elluminate for running clinical study listings. Telecommute up to 3 days per week; requires up to 5% domestic travel, fully reimbursed. Compensation Salary range: $142,500 to $256,500. Target pay range: $220,800 to $256,500. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law. Applicants with disabilities may request accommodations by contacting the company's personnel representative via phone or email. For assistance completing application forms or participation in the application process, call View phone number on click.appcast.io or email View email address on click.appcast.io. #J-18808-Ljbffr