Senior Manager, Clinical Data Management

Accountabilities:

• Serve as the lead data manager for assigned clinical studies and programs, establishing study-specific data management strategies, timelines, and deliverables.
• Review and approve key documentation, including Data Management Plans, Data Validation Plans, edit check specifications, eCRF specifications, and database build documentation.
• Provide hands-on oversight of Medidata Rave EDC database builds, including eCRFs, edit checks, custom functions, workflows, reports, and listings.
• Plan, execute, and document testing of database builds, eCRFs, edit checks, derivations, and system functionality, including defect assessment, resolution tracking, and UAT retesting.
• Lead data review, query management, external data reconciliation, and database lock activities while overseeing CRO and vendor deliverables.
• Monitor data quality, study metrics, and timelines to identify risks early and support external data integrations, transfer specifications, reconciliation, and inspection readiness.
• Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Pharmacovigilance, CROs, and external vendors to communicate progress, risks, decisions, and timelines.
• Review CRO financial reports, change notifications, and data management expenses to support scope, budget, and timeline management.
• Build productive relationships across internal teams and external partners, navigating challenging situations with professionalism and a solutions-oriented mindset.
• Identify opportunities to improve data management processes, standards, tools, and templates, and share best practices across clinical programs.
• Ensure day-to-day decisions align with study priorities, patient safety, data quality, compliance requirements, and broader program objectives.

Requirements:

• Bachelor’s degree in Life Sciences, Health Sciences, Computer Science, or a related discipline; an advanced degree is preferred.
• 7+ years of clinical data management experience within the pharmaceutical, biotechnology, or CRO industry.
• Hands-on experience with Medidata Rave EDC, eCOA, and RTSM.
• Demonstrated ability to create, run, review, and interpret Medidata Rave reports and listings for data review, cleaning, reconciliation, and oversight.
• Experience testing clinical database builds, UAT scripts, edit checks, eCRFs, and database changes, including defect documentation and retesting.
• Strong understanding of database design, edit checks, data review, query management, external data reconciliation, and database lock processes.
• Strong knowledge of ICH-GCP and applicable clinical research regulatory requirements.
• Experience reviewing CRO study finance reports, change notifications, and data management expenses.
• Excellent written, verbal, and interpersonal communication skills, with the ability to work effectively with both technical and non-technical stakeholders.
• Strong organizational and prioritization skills, with the ability to manage multiple studies, competing deadlines, changing requirements, and time-sensitive deliverables.
• Demonstrated ownership, accountability, follow-through, and attention to detail across study deliverables.
• Ability to operate effectively in a fast-paced, high-pressure environment while maintaining quality, compliance, and sound judgment.
• Strong problem-solving and risk-management skills, with the ability to make timely, risk-based decisions in ambiguous situations.
• Ability to influence stakeholders and drive accountability across internal teams and external partners without direct authority.
• Familiarity with Spotfire or similar data visualization and analytics tools is preferred.
• Experience in a small to mid-sized biotechnology environment is preferred.
• Familiarity with CDISC standards, risk-based data review methodologies, and external vendor data integrations is a plus.

Benefits:

• Base salary range of $140,000–$196,000 per year.
• Annual bonus eligibility.
• Equity compensation.
• Competitive benefits package.
• Opportunity to lead clinical data management activities across clinical-stage programs.
• Cross-functional collaboration with clinical, statistical, medical, safety, and external development teams.
• Opportunity to contribute to data management process improvements, standards, tools, and operational excellence.
• Environment focused on patient-centered execution, data quality, compliance, and innovation.
• Opportunity to work within a growing biotechnology organization advancing AI-enabled approaches to drug design and development.
• Equal employment opportunity and an inclusive workplace that values diverse perspectives and backgrounds.