Sr Director, Data Management and Clinical Programming

Senior Director of Data Management & Clinical Programming Key Accountabilities / Core Job Responsibilities Provide strategic leadership and development for Data Management (DM) and Clinical Programming (CP) teams across the full data lifecycle Oversee end-to-end DM and CP deliverables from study start-up through database lock and Clinical Study Report, ensuring quality, timeliness, and compliance Drive the evolution of DM and CP strategies, processes, standards, and capabilities to enhance efficiency and scalability Lead studies, projects, and functional initiatives to achieve quality, timeline, and budget objectives, including resource planning Provide oversight of CROs and vendors to ensure performance, quality, and adherence to SOPs, GCP, and regulatory requirements Advance data standards (e.g., CDISC/SDTM) and champion process and technology improvements Identify, assess, and proactively manage risks at both functional and study levels Communicate effectively with stakeholders and senior leadership to enable informed decision-making Build and maintain strong cross-functional partnerships to support seamless data delivery Align departmental priorities with corporate objectives and contribute to broader organizational goals Represent DM and CP in internal and external working groups and strategic initiatives Lead talent management activities, including hiring, performance management, development, and training compliance Qualifications & Skills (Requirements) BA/BS in relevant field 12+ years of relevant industry experience with 10+ years management experience Effective organizational and communication skills Technologically savvy Thorough knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, UAT, medical coding, and the drug development process Strong experience and knowledge in the application of data standards and clinical programming (R, SAS) Excellent supervisory, problem solving, negotiation and organizational skills Knowledge and understanding of non-CRF data flow, transfer, and integration Thorough knowledge of the database development process and DM lifecycle for non-interventional/exploratory and Phase I-IV studies, including pivotal, blinded, and randomized trials Previous relevant EDC experience required Strong team building and resource allocation experience Composure and strong conflict management skills Prior experience managing vendors and CROs Benefits / Compensation Salary range: $245,000.00 to $318,000.00 Competitive total rewards package including 401(k), healthcare coverage, and ESPP (plus other benefits) #J-18808-Ljbffr