Director of Data Management, Technical Operations & Standards

Location of role US- Gaithersburg, MD or Conshohocken, PA

Department Biometrics

Key Responsibilities This position will 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. This role requires a 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.

Key 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.
  
  

Supervisory Responsibility (If applicable):

This position will be responsible for managing a team of FT employees and contractors.

Education, Experience and Knowledge:

• 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.
• Software Requirements:
  
  

⁻ 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.
  
  

About the Company Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.