Senior Manager, Clinical Data Management

8–12 years of clinical data management experience. Substantial experience leading complex studies or multi-study portfolios. Proven leadership experience managing data teams and driving high-quality delivery. Deep expertise in EDC systems, CDISC standards, data cleaning and reconciliation processes. Knowledge of regulatory requirements (ICH-GCP, 21 CFR Part 11, GDPR). Strong communication skills with the ability to influence, collaborate, and lead across diverse teams. Highly organized, analytical, and committed to data integrity, operational excellence, and continuous improvement. Able to operate strategically while remaining hands-on with complex problem-solving.

Lead, mentor, and develop a team of Clinical Data Managers and CDM operations staff. Oversee workload allocation, staffing plans, competency development, and performance management. Provide senior oversight of end-to-end CDM activities across multiple studies. Ensure predictable delivery of data management milestones. Anticipate operational risks and lead resolution efforts. Collaborate closely with Clinical Operations, Biostatistics, Safety, Regulatory, Quality, Product, and Engineering. Serve as a senior CDM representative in cross-functional meetings. Lead the development, refinement, and adoption of CDM SOPs, templates, libraries, and operational playbooks. Drive initiatives to streamline workflows, strengthen data quality controls, and enhance scalability. Support digital transformation initiatives. Serve as a senior CDM point of contact for sponsors. Provide proactive updates, risk assessments, and strategic recommendations to stakeholders. Contribute to proposal development, data strategy discussions, and operational feasibility assessments.