Director Data Management - Kaztronix
Overview
Kaztronix seeks a Director of Data Management to lead clinical data management across rare disease programs. This role provides strategic oversight and operational leadership from study start-up through database lock while collaborating with internal cross-functional teams and external partners. The ideal candidate has deep expertise in clinical data management hands-on experience with Medidata Rave and proven ability to manage Contract Research Organizations to ensure high-quality timely delivery of clinical data. Thriving in collaborative fast-paced biotech environments where team members wear multiple hats and partner across functions.
What You'll Do11
- 1Lead all clinical data management activities across Phase I III clinical trials in rare disease therapeutic areas
- 2Provide strategic oversight of CROs responsible for data management execution ensuring quality compliance budget adherence and on-time deliverables
- 3Develop monitor and proactively manage CRO project plans timelines and KPIs
- 4Serve as primary internal data management expert collaborate with Clinical Operations Biostatistics Statistical Programming Clinical Development Medical Monitoring Pharmacovigilance Regulatory Affairs Quality and Clinical Supply teams
- 5Oversee study start-up activities including database design CRF development edit check specifications data transfer agreements and vendor integration
- 6Ensure timely review and resolution of data queries protocol deviations reconciliation activities and database lock deliverables
- 7Review and approve key data management documentation including Data Management Plans CRF Completion Guidelines Data Validation Plans and Database Lock Checklists
- 8Drive continuous process improvements implement best practices to enhance data quality operational efficiency and inspection readiness
- 9Support regulatory submissions by ensuring high-quality inspection-ready clinical datasets and documentation
- 10Assess vendor performance and provide ongoing oversight to meet contractual obligations and study timelines
- 11Partner with functional leaders to identify risks develop mitigation strategies and communicate project status to senior leadership
Requirements11
- 1Bachelor's degree in Life Sciences Computer Science Health Sciences or related field advanced degree preferred
- 2Minimum of 8 years progressive clinical data management experience within biotechnology or pharmaceutical industry
- 3Experience supporting clinical trials in rare disease therapeutic areas
- 4Strong hands-on experience with Medidata Rave including database development study conduct and database lock activities
- 5Demonstrated success managing and overseeing CROs including project management timeline oversight vendor performance and issue escalation
- 6Experience managing multiple concurrent clinical studies in fast-paced environment
- 7Thorough understanding of ICH-GCP CDISC standards FDA regulations and global clinical data management best practices
- 8Strong knowledge of EDC systems data cleaning processes coding dictionaries and external data reconciliation
- 9Excellent project management organizational and problem-solving skills
- 10Outstanding written and verbal communication skills with ability to influence cross-functional stakeholders
- 11Previous experience in small or emerging biotechnology companies requiring collaboration across multiple functional areas
Salary Insight
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Location
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