About the Role:Provides enterprise-level leadership for the Clinical Data Management function and is accountable for the strategy, governance, operating model, and delivery of high-quality, inspection-ready clinical data across the clinical development portfolio. Ensures organizational capability, operational excellence, and scalable processes that support regulatory submissions, portfolio execution, and business objectives.
Your Contributions (include, but are not limited to):- Lead the Clinical Data Management function and/or major CDM sub-functions across the clinical development portfolio to ensure accurate, complete, timely, high-quality, and inspection-ready clinical trial data deliverables
- Establish and evolve the CDM strategy, operating model, governance framework, resource planning approach, vendor ecosystem, and capability roadmap to support portfolio growth and business priorities
- Provide portfolio-level strategic and operational leadership across the clinical data lifecycle, including data collection strategy, EDC/database build strategy, external data integration, data review, reconciliation, database lock readiness, clinical data delivery, and vendor oversight
- Drive execution quality and predictability across the portfolio by establishing data quality plans, risk-based approaches, portfolio metrics, dashboards, governance mechanisms, and escalation pathways
- Ensure CDM provides early strategic input into protocol design, CRF design, data standards, endpoint implementation, data flow, and cross-study consistency to enable fit-for-purpose data collection and high-quality analysis-ready data
- Partner with senior leaders in Biostatistics and Statistical Programming to drive end-to-end traceability from protocol and CRF design through SDTM-ready and analysis-ready data, reducing downstream rework and improving analysis timelines
- Lead resolution of high-impact or cross-functional CDM issues, including data quality risks, database lock risks, external data reconciliation challenges, vendor performance concerns, submission-readiness issues, and process or operating model gaps
- Establish and oversee CRO, vendor, contractor, and external data provider governance models; ensure vendor strategy, performance, quality, timelines, issue resolution, and contractual deliverables support portfolio needs
- Represent CDM in senior cross-functional governance, portfolio, program, vendor, and operational forums; communicate risks, recommendations, decisions, tradeoffs, and progress to senior leadership
- Partner with Clinical Development, Clinical Operations, Biostatistics, Statistical Programming, Medical, Safety/PV, Regulatory, Quality, Clinical Systems/IT, and external partners to align CDM strategy with development priorities, regulatory expectations, program goals, and business needs
- Own development and continuous improvement of CDM processes, standards, templates, work practices, governance mechanisms, and quality frameworks to increase operational efficiency, inspection readiness, and consistency across the portfolio
- Lead CDM technology enablement and modernization strategy, including scalable EDC build approaches, standard libraries, reusable CRFs/edit checks, automation, AI-enabled data review workflows, data quality surveillance, and solutions supporting end-to-end biometrics standardization
- Ensure the CDM function operates in accordance with applicable regulations, Good Clinical Practice, ICH guidelines, Good Clinical Data Management Practices, SOPs, work instructions, data integrity expectations, and study-specific requirements
- Provide senior leadership for CDM-related inspections, audits, quality reviews, data integrity initiatives, submission-readiness activities, and corrective/preventive action plans
- Build, lead, and develop a high-performing CDM organization; manage leaders and/or senior professionals, strengthen role clarity, decision quality, accountability, empowerment, career development, and succession planning.
- Own or provide senior-level input into resource planning, budget planning, vendor proposal review, staffing strategy, outsourcing strategy, and timeline planning for the CDM function or assigned portfolio
- Monitor industry trends, technologies, data standards, outsourcing models, and evolving regulatory expectations related to CDM; identify and lead strategic process, system, or operating model improvements
- Perform other duties as assigned
Requirements:- BS/BA degree in Computer Science, life science, or related field AND 14+ in Clinical Data Management in a biopharmaceutical setting (industry and/or CRO OR
- Master's degree in Computer Science, life science or related field AND 12+ years of similar experience noted above OR
- PhD in Computer Science, life science or related field AND 10+ years of similar experience noted above
- Senior leadership experience in Clinical Data Management across multiple clinical programs, development phases, and/or therapeutic areas in the biotechnology, pharmaceutical, or CRO environment
- Strong working knowledge of the clinical data lifecycle, including data collection strategy, CRF design, EDC/database build strategy, external data integration, data review, reconciliation, database lock, regulatory submission readiness, and clinical data delivery
- Demonstrated ability to establish or evolve CDM strategy, operating model, governance frameworks, standards, resource planning, vendor strategy, and leadership capability for a growing clinical development portfolio
- Strong working knowledge of EDC platforms and related CDM systems; Medidata Rave experience preferred
- Deep experience with clinical data standards, including CDASH, SDTM, controlled terminology, standard CRF libraries, global libraries, reusable edit checks, and cross-study standardization
- Demonstrated ability to partner with senior leaders in Biostatistics and Statistical Programming to drive fit-for-purpose data collection, end-to-end traceability, biometrics standardization, and analysis-ready data delivery
- Proven experience establishing and overseeing CROs, vendors, contractors, and external data providers in outsourced or hybrid operating models
- Deep knowledge of GCP, ICH guidelines, regulatory expectations, data integrity principles, SOPs, inspection-readiness requirements, and submission-supporting data expectations
- Experience establishing portfolio-level CDM metrics, dashboards, and governance mechanisms to drive quality, predictability, vendor performance, cycle time reduction, and database lock readiness
- Demonstrated ability to lead functional transformation, process improvement, technology enablement, and modernization efforts, including scalable EDC build approaches, standard libraries, automation, AI-enabled data review workflows, data visualization, and/or data quality surveillance
- Strong people leadership experience, including leading leaders, developing senior professionals, building high-performing teams, and strengthening succession planning
- Strong executive communication, influence, collaboration, decision-making, and stakeholder management skills in a fast-paced, matrixed environment
- Demonstrated ability to lead through ambiguity, align cross-functional stakeholders, manage competing priorities, and make sound tradeoff decisions that support portfolio and business objectives
#LI-KM1
The annual base salary we reasonably expect to pay is $221,500.00-$302,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
