Manager, Clinical Data Systems

Role Summary

Lead the design, delivery, and integration of clinical data systems (e.g., EDC, IRT, ePRO). Ensure systems meet data standards and regulatory requirements, align with program and study objectives, and optimize functionality and data flow. Partner with DSS (Data and Statistical Sciences) and cross-functional teams to synchronize work across upstream and downstream dependencies, coach team members, and drive innovation and process improvements.

Responsibilities

• Actively participates in the development of common data standards and ensures system designs comply with these standards and with associated protocol requirements. Ensures that the design team utilizes standards.
• Establishes and maintains the methodology used by the team to design and develop clinical trial systems, benchmarking against industry standards. Ensures that systems are specified to optimize functionality, end user experience, and data flow. Ensures that the design team meets these expectations.
• Ensures that TA- and program-level consistency is achieved by the design team.
• Accountable for on-time design and delivery of new clinical systems, integrations between systems, and any required changes to clinical systems (e.g., EDC, IRT, ePRO). Utilizes project management tools to track study progress and plan work. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions.
• Interacts with and influences DSS and cross-functional team members to achieve program and study objectives; ensures assigned work products are synchronized with upstream and downstream dependencies.
• Ensures adherence to applicable regulations and quality standards (e.g., GCPs, ICH guidelines, SOPs) and stays abreast of evolving regulations and policies related to clinical development.
• Responsible for coaching and mentoring members of the team, as well as contributing to their skill development.
• Leads DSS and cross-functional innovation and process improvement initiatives.

Qualifications

• Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent; master’s degree preferred.
• 5+ years of clinical technology experience (e.g., EDC, IRT, ePRO) or 7+ years in a similar technical role or clinical development role; experience with common industry design and development tools required.
• Deep knowledge of the clinical trial process, including CDASH and SDTM.
• Proven track record as a key contributor to initiatives and organizational advancement.
• Ability to influence others without direct authority; proven coaching/mentoring skills in a matrixed environment; strong communication and analytical abilities.

Education

• Bachelor’s degree in business, management information systems, computer science, life sciences, or equivalent; master’s degree preferred.