Senior Clinical Data Manager

Why RTI

RTI International is an independent, scientific research institute dedicated to improving the human condition. Our vision is to address the world's most critical problems with technical and science-based solutions in pursuit of a better future. Clients rely on us to answer questions that demand an objective and multidisciplinary approach-one that integrates expertise across social, statistical, data, and laboratory sciences, engineering, and other technical disciplines to solve the world's most challenging problems.

The Senior Clinical Data Manager (Sr. CDM) is a strategic and hands-on leader responsible for overseeing end-to-end data management activities across multiple global clinical trials. This role ensures the integrity, accuracy, and completeness of clinical trial data in compliance with Good Clinical Practice (GCP), regulatory guidelines, and company standard operating procedures (SOPs). The Sr. CDM serves as the primary liaison between internal teams, contract research organizations (CROs)/external vendors, providing oversight, guidance, and innovation in all aspects of data management.

With deep expertise in data systems and standards, this role plays a critical part in accelerating timelines, supporting regulatory submissions, and driving the overall success of clinical development programs.

• Act as the lead data manager and provide the associated expertise for assigned Phase II/III trials, ensuring timely delivery of high-quality, submission-ready data.
• In collaboration with trial statisticians, provide strategic input into study designs, protocol development, and data collection strategies to optimize trial efficiency and data flow.
• Ability to oversee and perform work to author, maintain, and implement study-level data management plans (DMPs), CRF/eCRF specifications, edit checks, validation rules, and other key documentation.
• Drive continuous alignment of data management strategy with overall program milestones and regulatory objectives.

• Ensure accuracy, consistency, and completeness of trial data through ongoing review, cleaning, and reconciliation (SAE, labs, imaging, biomarkers, PK, PRO/ePRO, etc.).
• Lead data review meetings, ensuring timely identification and resolution of discrepancies.
• Coordinate interim analyses, database snapshots, and final database lock, ensuring data integrity for regulatory filings and publications.
• Champion and help design and implement risk-based monitoring (RBQM), centralized data review, and technology-enabled approaches to enhance efficiency and reliability of data cleaning.
• Ability to oversee and perform work involved in adoption of CDISC standards (SDTM/ADaM) in case report form development and dataset creation.

• Routinely collaborate and liaise with Clinical Operations, Programming, Biostatistics, Medical Monitoring, and Safety throughout trial development, implementation and to ensure alignment of data deliverables with trial and submission objectives.
• In collaboration with Clinical Operations and Biostatistics, design and develop data driven clinical trial surveillance reports to ensure quality of data at the trial and site level.
• In collaboration with Clinical Operations and Biostatistics, ensure data collection, completion and cleaning occurs per expected timelines and support escalation and resolution of identified issues.
• Collaborate with Clinical Operations and Medical Monitors in pharmacovigilance data management and regulatory reporting.
• Deliver high-quality datasets, listings, and reports to support regulatory submissions (NDA, BLA, MAA) and health authority inspections.
• Collaborate on clinical study reports (CSRs), publications, and scientific presentations, ensuring data accuracy and consistency.

• Provide oversight, governance, and quality management of CRO data management deliverables, holding vendors accountable to timelines, budget, and quality.
• Review and approve vendor data transfer specifications, reconciliation reports, quality metrics, and compliance documentation.
• Proactively identify and elevate risks, implementing corrective actions to ensure successful partnership and delivery.

• Bachelor's degree in Life Sciences, Computer Science, or a related field and a minimum of 8 years of progressive experience in clinical data management within a biotech, pharmaceutical, or CRO environment for trials conducted under INDs or equivalent experience. Equivalent experience is a master's degree and 6 years of experience. Master's degree preferred.
• Proven track record of leading global Phase II/III clinical trials through development, database lock, and submission.
• Deep understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements, including expertise in medical coding, CDISC standards (SDTM, ADaM), and associated electronic data submission to regulatory agencies.
• Proficiency with…