Director, Data Management
Protara Therapeutics
4 months ago
Remote friendly (New York, NY)
United States
IT
Job Overview
- Strategic and hands-on leadership overseeing the design, implementation, and oversight of clinical data systems and processes across multiple clinical development programs (including projects contracted with CROs and internal projects).
Essential Duties and Responsibilities
- Develop and execute 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 aligns with scientific and regulatory requirements.
- Review and contribute to clinical protocols and statistical analysis plans; ensure cross-project consistency and standardized 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.
- 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 to ensure alignment with contractual deliverables and performance expectations.
- Establish standards/oversight for EDC setup, CRF development, data validation, discrepancy management, and database lock.
- Drive consistency and scalability via implementation of standards (e.g., CDISC/CDASH/SDTM) and SOPs.
- Develop and improve clinical data management processes and tools.
- Evaluate organizational needs, define resource strategies, and manage departmental budgets and headcount planning.
Qualifications
- Bachelor’s degree in related scientific discipline; advanced degree preferred.
- 10+ years (Director level) progressive experience in clinical data management OR 8+ years (Director level) progressive experience with significant leadership responsibility in biotech/pharma.
- Expert knowledge of clinical data management.
- Deep expertise in industry standards: CDISC/CDASH, SDTM, ICH-GCP, 21 CFR Part 11, and regulatory submission requirements.
- Proven success leading large-scale global studies, vendor oversight, and experience in both in-house and outsourced models.
- Hands-on experience with EDC systems (e.g., Medidata Rave, Veeva), clinical systems integration, and risk-based monitoring frameworks.
- Exceptional leadership, analytical, and communication skills; ability to influence senior stakeholders/executives.
Computer Skills
- Proficient in MS Office Suite and EDC systems.
Other Skills and Abilities
- Strong interpersonal skills; communicate effectively with diverse audiences and build relationships.
- Excellent written and oral communication and presentation skills.
- Ability to prioritize and multitask in a fast-paced environment.
- Strong organizational skills and attention to detail.
- Ability to work with highly confidential information.
- Ability to manage day-to-day operations and project work in a fast-paced environment.
- Strong analytical and problem-solving skills.
- Ability to work independently and collaboratively.
- Experience working with and presenting to senior level management.
- Ability to work through uncertainty.
- Strategic and hands-on leadership overseeing the design, implementation, and oversight of clinical data systems and processes across multiple clinical development programs (including projects contracted with CROs and internal projects).
Essential Duties and Responsibilities
- Develop and execute 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 aligns with scientific and regulatory requirements.
- Review and contribute to clinical protocols and statistical analysis plans; ensure cross-project consistency and standardized 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.
- 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 to ensure alignment with contractual deliverables and performance expectations.
- Establish standards/oversight for EDC setup, CRF development, data validation, discrepancy management, and database lock.
- Drive consistency and scalability via implementation of standards (e.g., CDISC/CDASH/SDTM) and SOPs.
- Develop and improve clinical data management processes and tools.
- Evaluate organizational needs, define resource strategies, and manage departmental budgets and headcount planning.
Qualifications
- Bachelor’s degree in related scientific discipline; advanced degree preferred.
- 10+ years (Director level) progressive experience in clinical data management OR 8+ years (Director level) progressive experience with significant leadership responsibility in biotech/pharma.
- Expert knowledge of clinical data management.
- Deep expertise in industry standards: CDISC/CDASH, SDTM, ICH-GCP, 21 CFR Part 11, and regulatory submission requirements.
- Proven success leading large-scale global studies, vendor oversight, and experience in both in-house and outsourced models.
- Hands-on experience with EDC systems (e.g., Medidata Rave, Veeva), clinical systems integration, and risk-based monitoring frameworks.
- Exceptional leadership, analytical, and communication skills; ability to influence senior stakeholders/executives.
Computer Skills
- Proficient in MS Office Suite and EDC systems.
Other Skills and Abilities
- Strong interpersonal skills; communicate effectively with diverse audiences and build relationships.
- Excellent written and oral communication and presentation skills.
- Ability to prioritize and multitask in a fast-paced environment.
- Strong organizational skills and attention to detail.
- Ability to work with highly confidential information.
- Ability to manage day-to-day operations and project work in a fast-paced environment.
- Strong analytical and problem-solving skills.
- Ability to work independently and collaboratively.
- Experience working with and presenting to senior level management.
- Ability to work through uncertainty.