Protara Therapeutics

Director

• 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.

Director, Data Management