Director of Data Management, Technical Operations & Standards

Role Summary

Director of Data Management, Technical Operations & Standards – oversee 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. Focus on EDC systems, CDISC data standards, and regulatory requirements for system management to ensure data integrity, accuracy, and timeliness in support of trial outcomes.

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 and systems, proactively identify and resolve issues, and ensure studies are set up and designed per protocol.
• Ensure compliance with 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 data integrity and quality through validation and monitoring.
• Oversee vendor management; partner with Clinical Development and IT to select, qualify, and manage external eClinical vendors, ensuring regulatory and quality compliance.
• 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, CRF design, and data validation processes.
• Medidata Rave: extensive experience essential; familiarity with 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; 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; alignment with STRIDE values; entrepreneurial mindset.

Education

• As listed in Qualifications above.

Additional Requirements

• Location: US - Gaithersburg, MD or Conshohocken, PA.
• No specific travel details provided.