Senior Manager, Development Systems

This role reports to Director, Development Systems and is a key strategic partner across Clinical Development, Clinical Operations, Data Management, IT, Quality Assurance, and technology vendors, translating business needs into scalable technical solutions while ensuring compliance and data integrity. Serving as the Development Systems subject matter expert (SME), this role will establish organizational change management strategies, build adaptability, drive cross-functional adoption of technology and processes, and delivery operational excellence across Development functions.

This is a hybrid role typically requiring on-site presence 3 days per week.

Responsibilities

GxP System Management & Business Process Alignment

• Partner with business stakeholders and QA to map end-to-end business processes and develop SOPs, work instructions, and training materials that drive compliance and operational consistency
• Lead the configuration, business administration, and lifecycle management of GxP applications to ensure reliable performance, regulatory compliance, and alignment with evolving business needs
• Analyze vendor release notes and perform technical and regulatory impact assessments to mitigate system risks and maintain GxP compliance during vendor releases
• Manage GxP system release projects end-to-end from planning, risk assessment, change control, and validation through deployment—measuring success against approved timelines, validation acceptance criteria, release readiness, and post-release system performance
• Oversee clinical study data migration and integration initiatives by architecting secure data pipelines and developing lifecycle documentation, including specifications, migration plans and requirements, and validation deliverables, to ensure data integrity and GxP compliance
• Conduct GxP system periodic and audit trail reviews to ensure inspection readiness

Operational Excellence & Organization Change Management

• Partner with BPO to design comprehensive change management strategies and end-user support materials. Manage system release communications and training to enable successful system adoption, ensure business process compliance, and enhance operational effectiveness
• Lead role-based system training and study onboarding for Rave CTMS and Veeva Clinical
• Establish processes to capture user feedback and monitor success metrics, leverage system knowledge to continuously optimize training, support, and release rollout strategies
• Spearheads post-release reviews to capture lessons learned, elevate cross-functional transparency, and implement process enhancements that optimize future system deployments
• Drive system reliability and operational excellence by partnering with IT and vendors to turn performance and support insights into proactive issue resolution and functional improvements

Preferred Skills, Qualifications and Technical Proficiencies

• Deep understanding of GCP and GxP regulations (FDA 21 CFR Part 11, EU Annex 11, GAMP5)
• Results-driven leader with exceptional attention to detail and track record of delivering high-quality business outcomes in complex, fast-paced, and highly regulated environments
• Proven ability to prioritize competing demands, solve complex business challenges, and translate strategic goals into innovative solutions and measurable outcomes

Preferred Education and Experience

• Bachelor’s degree in Computer Science, Data Science, Life Sciences, or a related field
• 5 years of firsthand experience in GxP application support and project management
• 5 years of experience in CSV and system change controls in a GxP regulated environment (pharmaceutical, biotech, medical device)
• Experience supporting clinical systems, including CTMS, eTMF, and R&D information platforms