Director of Data Management, Technical Operations & Standards

Role Summary

Director of Data Management, Technical Operations & Standards. Location: US- Gaithersburg, MD or Conshohocken, PA. Department: Biometrics.

Responsibilities

• Lead and manage the data management strategy for clinical trials, ensuring adherence to industry standards and regulatory requirements.
• Oversee the implementation and maintenance of EDC systems, ensuring efficient data capture and processing.
• Develop and enforce CRF standards to ensure consistency and accuracy in data collection.
• Ensure the integrity and quality of clinical data through rigorous validation and monitoring processes.
• Ensure compliance with all relevant regulatory requirements, including FDA, EMA, and ICH guidelines.
• Work closely with clinical operations, biostatistics, and other departments to align data management efforts with broader clinical development goals.
• Oversee vendor management; select, qualify, and manage external EDC vendors, ensuring compliance with regulatory and quality standards.
• Track the performance of EDC vendors, systems, proactively identify and resolve issues, and ensure studies are setup and designed per protocol.
• 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 EDC systems, CRF design, and data validation processes.
• Medidata Rave: Extensive experience with Medidata Rave 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 Immunocore's values of respect, trust, integrity, and diversity.
• Entrepreneurial mindset with a passion for innovation and improvement.