Director of Data Management, Technical Operations & Standards

Role Summary

Director of Data Management, Technical Operations & Standards responsible for the design, integration, and governance of eClinical systems and data flows to ensure interoperability, regulatory compliance, and operational efficiency across the clinical development data lifecycle. The role requires deep understanding of Electronic Data Capture (EDC) systems, CDISC data standards, and regulatory requirements for system management. The Director will ensure the integrity, accuracy, and timeliness of clinical data, driving successful trial outcomes and compliance with industry standards.

Responsibilities

• Lead and manage the eClinical strategy for clinical trials, ensuring adherence to industry standards and regulatory requirements.
• Support the implementation and maintenance of EDC, eCOA, ePro and other clinical systems, ensuring efficient data capture and processing.
• Lead study start-up planning, CRF standards, edit check strategy, and database lock processes.
• Track the performance of EDC vendors, systems, proactively identify and resolve issues, and ensure studies are setup and designed per protocol.
• Ensure compliance with all relevant regulatory requirements, including FDA, EMA, and ICH guidelines. Oversee system validation per 21 CFR Part 11, GxP, and GDPR compliance.
• Promote AI and automation for query optimization, edit check generation, and data review.
• Develop and oversee eClinical data governance for metadata, CDISC standards, and controlled terminology. Ensure the integrity and quality of clinical data through rigorous validation and monitoring processes.
• Oversee vendor management; partner with groups across Clinical Development and IT to select, qualify, and manage external eClinical vendors, ensuring compliance with regulatory and quality standards.
• Oversee inspection readiness activities, including audits and regulatory inspections related to clinical trial conduct.
• Other duties as needed.

Qualifications

• Bachelor's degree in Life Sciences, Computer Science, or related field with 16+ years of work experience; advanced degree preferred.
• Minimum of 10 years of experience in clinical data management, with at least 5 years in a leadership role.
• Proficiency in technical management of eClinical systems with a focus on EDC systems, CRF design, and data validation processes.
• Medidata Rave: extensive experience is essential; familiarity with other clinical data management software such as Oracle Clinical, SAS, and CDISC standards.
• Proven experience in creating and implementing edit checks to ensure data accuracy and consistency.
• Strong understanding of FDA, EMA, and ICH guidelines.
• Proven ability to lead and manage cross-functional teams.
• Excellent verbal and written communication skills; strong analytical and problem-solving abilities.
• Demonstrated ability to lead with science to benefit patients.
• Strong alignment with values of respect, trust, integrity, and diversity; entrepreneurial mindset with a passion for innovation and improvement.

Education

• Bachelor's degree in Life Sciences, Computer Science, or related field; advanced degree preferred.