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 Deep expertise in EDC systems Deep expertise in CDISC standards Deep expertise in data cleaning and reconciliation processes Deep expertise in regulatory requirements (ICH-GCP, 21 CFR Part 11, GDPR) Strong communication skills Ability to influence, collaborate, and lead across diverse technical and operational teams Highly organized, analytical Committed to data integrity, operational excellence, and continuous improvement Able to operate strategically Able to remain 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. Foster a culture of excellence, continuous improvement, and accountability. 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 with Clinical Operations, Biostatistics, Safety, Regulatory, Quality, Product, and Engineering. Serve as a senior CDM representative in cross-functional study meetings. Align CDM workflows with broader study goals and portfolio-level priorities. 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.