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.

• Represent CSSM and trial‑level user needs in system enhancements, implementations, and ongoing optimization efforts.
• Act as a liaison between CSSM Center of Excellence, CSSM users, Business System Owners, 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 to provide scalable user support, knowledge sharing, and consistent system utilization.
• 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 or process updates.
• Design and deliver training programs to support CSSM users across clinical systems and trial processes.
• Develop targeted training materials and communications for new system implementations, enhancements, and process updates.
• Partner with Change Management teams to drive adoption and ensure effective transition to new ways of working.
• Analyze trial‑level workflows to identify inefficiencies and opportunities for technology‑enabled improvements.
• Support continuous improvement initiatives aligned to CSSM and trial execution needs.
• Contribute to innovation pilots and implementation of new digital or system capabilities.
• Promote high‑quality, timely, and compliant data entry within clinical systems (e.g., CTMS, eTMF).
• Partner with RSLs, CSSM Systems SMEs, and 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.

• Bachelor’s Degree or equivalent in a relevant area.
• 2+ years of Clinical Sciences and Study Management (CSSM) experience.
• SME Network Leadership experience.
• Change & Adoption Leadership experience.

• 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

• None specified.

US and Puerto Rico Residents Only. San Francisco Residents Only: will consider qualified applicants with arrest and conviction records in compliance with the San Francisco Fair Chance Ordinance.

Los Angeles Residents Only: will consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local laws.

Salary range: $ – $. The salary is based on factors such as education, qualifications, certifications, experience, skills, location, and business needs. Eligible candidates may receive annual bonus and long‑term incentive, if applicable.

Benefits include medical, dental, vision healthcare and other insurance benefits for employee and family, retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days. For more information see Merck Benefits Portal.

As an Equal Employment Opportunity…