Director, Data Management

Role Summary

Director, Data Management. Lead the clinical Data Management function across multiple drug development programs, providing strategic leadership and hands-on management of data management activities, standards (CDASH/SDTM), and vendor oversight within a Biometrics team.

Responsibilities

• Provide clinical data management leadership to align on and drive data collection requirements to set a high-performance and collaborative culture.
• Plan, coordinate, and deliver complete, high-quality, reliable clinical trial data in a timely manner for assigned projects.
• Oversee end-to-end clinical data management activities, representing data management on internal cross-functional teams and with regulatory agencies.
• Provide quality and project oversight over third-party data management vendors.
• Maintain quality processes for data management through SOP ownership, training, and inspection readiness; establish best-in-class data generation and reporting standards.
• Collaborate with internal and external teams to plan and execute day-to-day data management deliverables.
• Provide expertise on CDASH and CDISC data standards to the Clinical Development team.
• Engage with senior leaders across functions for strategic planning to optimize clinical development aligned with corporate objectives.
• Oversee database status with respect to KPIs, metrics, and program-level deliverables and timelines.
• Contribute to resource planning, re-forecasting, and program milestones.
• Evaluate and recommend new data management technologies and systems for improved functionality.
• Resolve complex issues and proactively develop solutions; communicate clearly and collaborate to drive resolution across functions.
• Manage resource assignments to ensure appropriate data quality oversight for clinical trials.

Qualifications

• BA/BS in Computer Science or closely related scientific field required
• Master‚Äôs or other advanced degree highly preferred
• 10+ years of clinical/statistical data management within the biotech/pharmaceutical industry
• 3+ years of leadership experience
• Experience developing and implementing clinical data management standards and procedures
• Strong problem-solving skills and attention to detail
• Experience leading teams supporting NDA and IND filings
• Ability to establish and articulate a team plan and direction
• Experience outsourcing and managing CDM vendors and contractors
• Strong analytical skills with experience in clinical research and drug development data
• Extensive experience interacting with regulatory agencies in GCP inspections/audits (US and non-US)
• Proven leadership and project management abilities with cross-functional influence
• Excellent verbal and written communication
• Adaptable to changing priorities; detail-oriented and resilient under pressure
• Ability to evaluate business impact of decisions and remain flexible
• Strong analytical, problem-solving, and organizational skills with multi-tasking ability
• Ability to convey technical information to non-scientists and educate the internal team
• Team player with strong collaboration skills

Education

• BA/BS in Computer Science or related field required; advanced degree preferred