Tenacious in our search for transformative therapies
Director, Data Management
Location
New York
Posted
58 days ago
Salary
$225K - $230K / year
Seniority
Lead
Job Description
Director, Data Management
Protara Therapeutics
• Development and execution of data quality strategies, risk-based data review plans, and cross-study harmonization. • Direct the design, testing, validation, and maintenance of clinical databases and electronic data capture (EDC) systems. • Ensure consistent application of CDM standards, tools (e.g., CDISC, Medidata Rave), and procedures. • Oversee issues resolution and data integrity across outsourced vendors and internal teams. • Provide proactive input into clinical protocol design to ensure data collection strategies align with scientific and regulatory requirements. • Review and contribute to clinical protocols and statistical analysis plans to ensure alignment with data collection objectives; cross-project consistency and standardization of case report forms. • Partner with internal stakeholders to align timelines and data delivery requirements. • Participate in cross-functional study teams; influence protocol design, study setup, and data strategy from study start to submission. • Actively support submission readiness, including data integration and final deliverables for regulatory filings. • Participate in protocol development, clinical study reports (CSR), and submission activities. • Manage relationships with CROs and third-party vendors, ensuring alignment with contractual deliverables and performance expectations. • Establish standards and oversight processes for EDC setup, CRF development, data validation, discrepancy management, and database lock. • Drive consistency and scalability through implementation of standards (e.g., CDISC/CDASH/SDTM) and SOPs. • Development and improvement of clinical data management processes and tools. • Participates in the evaluation of organizational needs, defining resource strategies, and managing departmental budgets and headcount planning.
Job Requirements
- Bachelor’s degree in related scientific discipline; advanced degree preferred.
- 10+ years of progressive experience in clinical data management for Director level, 8+ years of progressive experience in clinical data management for Director level, with significant leadership responsibility at a biotech/pharma organization.
- Expert knowledge of clinical data management.
- Deep expertise in industry standards including CDISC/CDASH, SDTM, ICH-GCP, 21 CFR Part 11, and regulatory submission requirements.
- Proven success leading large-scale global studies, vendor oversight and working in both in-house and outsourced models.
- Expertise knowledge and hands on experience with EDC systems (e.g., Medidata Rave, Veeva), clinical systems integration, and risk-based monitoring frameworks required.
Benefits
- Competitive Compensation & Benefits package including incentive bonus, equity compensation, matching 401(k), medical, dental, vision, commuter, and fertility benefits.
- Generous Paid Holidays and Unlimited PTO.
- Flexible working hours/schedule.
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