Associate Director, CSSM Systems Lead, Hybrid

Job Description

Our Clinical Research and Pharmacovigilance teams advance global healthcare through clinical research and innovation. In support of Global Clinical Trial Operations (GCTO), this role ensures effective execution of trial-level processes supported by technology by representing Clinical Sciences & Study Management (CSSM) user needs and driving adoption of business systems.

• The CSSM Systems Lead is responsible for representing trial-level operational needs and CSSM business processes in the design, implementation, and ongoing optimization of clinical systems. This role serves as a key liaison between CSSM users, Business System Owners (BSOs) for applicable systems, and IT to ensure systems effectively support trial execution.

• Bachelor's Degree or equivalent in relevant area

• 2+ years of Clinical Sciences and Study Management experience (CSSM)
• SME Network Leadership
• Change & Adoption Leadership

• Represent CSSM and trial-level user needs in system enhancements, implementations, and ongoing optimization efforts.
• Act as a key liaison between CSSM Center of Excellence team, CSSM users, BSOs, systems SMEs and IT to ensure technology solutions align with trial execution requirements.
• Partner with Global Clinical Development process owners, CSSM CoE and CSSM leadership to ensure systems support end-to-end trial processes.

• Build and sustain a high-performing CSSM Systems SME network, enabling scalable user support, knowledge sharing, and consistent system utilization. Set clear expectations for type of support to be provided by these SMEs, define escalation pathway for users to follow for issues and how-to questions.
• Serve as a point of contact for CSSM Systems SMEs for system-related inquiries, issues, and escalations.
• Collaborate with IT product teams, Technology Operations & Services (TOPS) team, and BSOs to troubleshoot system issues and identify root causes.
• Identify recurring challenges and drive improvements through system enhancements and/or process updates.

• Work with CSSM CoE, Regional Systems Leads (RSLs) and CSSM Systems SMEs to design and deliver training programs to support CSSM users across clinical systems and trial processes.
• Work with BSOs for applicable systems and tools to develop targeted training materials and communications to support new system implementations, enhancements, and process updates.
• Partner with Change Management teams to drive adoption and ensure effective transition to new ways of working and drive better system use.

• Analyze trial-level workflows to identify inefficiencies and opportunities for technology-enabled improvements.
• Support continuous improvement initiatives aligned to CSSM and trial execution needs.
• Support innovation pilots and contribute to the implementation of new digital or system capabilities.

• Promote and support high-quality, timely, and compliant data entry within clinical systems (e.g., CTMS, eTMF).
• Partner with RSLs, CSSM Systems SMEs, Data Integration & Automation (DIA) team to address data quality issues and ensure adherence to Global Clinical Development procedures.
• Support activities related to data monitoring, issue resolution, and compliance readiness.

• Engage regularly with CSSM CoE, other CSSM stakeholders and trial teams to gather feedback and communicate updates.
• Analyze system usage, data quality, and user behavior trends to proactively identify risks, inefficiencies, and improvement opportunities.
• Partner with CSSM CoE communications teams to ensure clear, effective messaging to CSSM users.

• Change Management
• Clinical Project Management
• Clinical Trial Management Systems (CTMS)
• Clinical Trials Operations
• Communication
• Cross-Functional Collaboration
• Influencing Skills
• Process Improvements
• Root Cause Analysis (RCA)
• Stakeholder Management
• Training and Development

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