The ideal candidate brings deep expertise in clinical data management, hands-on experience with Medidata Rave, and a proven ability to manage Contract Research Organizations (CROs) to ensure high-quality, timely delivery of clinical data. This individual will provide strategic oversight and operational leadership for data management from study start-up through database lock while collaborating closely with internal cross-functional teams and external partners.

Director, Data Management

Position Summary

We are seeking an experienced Director of Data Management to lead clinical data management activities across multiple rare disease clinical development programs. This individual will provide strategic oversight and operational leadership for data management from study start-up through database lock while collaborating closely with internal cross-functional teams and external partners.

The ideal candidate brings deep expertise in clinical data management, hands-on experience with Medidata Rave, and a proven ability to manage Contract Research Organizations (CROs) to ensure high-quality, timely delivery of clinical data. This role is well suited for someone who thrives in a collaborative, fast-paced biotech environment where team members wear multiple hats and partner across functions.

Key Responsibilities

• Lead all clinical data management activities across Phase I III clinical trials in rare disease therapeutic areas.
• Provide strategic oversight of CROs responsible for data management execution, ensuring quality, compliance, budget adherence, and on-time deliverables.
• Develop, monitor, and proactively manage CRO project plans, timelines, milestones, and key performance indicators.
• Serve as the primary internal data management expert and collaborate with Clinical Operations, Biostatistics, Statistical Programming, Clinical Development, Medical Monitoring, Pharmacovigilance, Regulatory Affairs, Quality, and Clinical Supply teams.
• Oversee study start-up activities including database design, CRF development, edit check specifications, data transfer agreements, and vendor integration.
• Ensure timely review and resolution of data queries, protocol deviations, reconciliation activities, and database lock deliverables.
• Review and approve key data management documentation, including Data Management Plans, CRF Completion Guidelines, Data Validation Plans, and Database Lock Checklists.
• Drive continuous process improvements and implement best practices to enhance data quality, operational efficiency, and inspection readiness.
• Support regulatory submissions by ensuring high-quality, inspection-ready clinical datasets and documentation.
• Assess vendor performance and provide ongoing oversight to ensure contractual obligations and study timelines are met.
• Partner with functional leaders to identify risks, develop mitigation strategies, and communicate project status to senior leadership.
• Stay current on industry trends, regulatory expectations, and evolving data management technologies.

Qualifications

Required

• Bachelor's degree in Life Sciences, Computer Science, Health Sciences, or a related field; advanced degree preferred.
• Minimum of 8 years of progressive clinical data management experience within the biotechnology or pharmaceutical industry.
• Experience supporting clinical trials in rare disease therapeutic areas.
• Strong hands-on experience with Medidata Rave, including database development, study conduct, and database lock activities.
• Demonstrated success managing and overseeing CROs, including project management, timeline oversight, vendor performance, and issue escalation.
• Experience managing multiple concurrent clinical studies in a fast-paced environment.
• Thorough understanding of ICH-GCP, CDISC standards, FDA regulations, and global clinical data management best practices.
• Strong knowledge of EDC systems, data cleaning processes, coding dictionaries, and external data reconciliation.
• Excellent project management, organizational, and problem-solving skills.
• Outstanding written and verbal communication skills with the ability to influence cross-functional stakeholders.

Preferred

• Experience supporting early-phase and late-phase clinical development programs.
• Experience with central laboratory, ePRO/eCOA, imaging, and other external clinical data sources.
• Familiarity with RBQM principles and risk-based data review methodologies.
• Previous experience in a small or emerging biotechnology company where collaboration across multiple functional areas is essential.

Success Profile

The successful candidate is a collaborative leader who is comfortable operating in a lean organization, balancing strategic leadership with hands-on execution. They are highly organized, proactive, and capable of building strong partnerships with internal stakeholders and external vendors to ensure clinical data are accurate, complete, and delivered on schedule.

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.