Associate Director, CSSM Systems Lead, Hybrid
Merck
June 29, 2026
Remote friendly (Rahway, NJ)
United States
IT
Position Description
- CSSM Systems Lead responsible for representing trial-level operational needs and CSSM business processes in the design, implementation, and ongoing optimization of clinical systems.
- Liaison between CSSM users, Business System Owners (BSOs) and IT to ensure systems support trial execution.
Core Accountabilities and Duties
Trial-Level Business Representation
- Represent CSSM and trial-level user needs in system enhancements, implementations, and ongoing optimization.
- Liaison among CSSM CoE, CSSM users, BSOs, systems SMEs and IT to align technology solutions with trial execution requirements.
- Partner with Global Clinical Development process owners, CSSM CoE and CSSM leadership to support end-to-end trial processes.
User Support & Issue Management
- Build and sustain a CSSM Systems SME network; set support expectations and define escalation paths.
- Point of contact for system inquiries, issues and escalations.
- Collaborate with IT product teams, TOPS, and BSOs to troubleshoot issues and identify root causes.
- Identify recurring challenges and drive improvements via system enhancements and/or process updates.
Training & Change Management
- Design and deliver training programs with CSSM CoE, Regional Systems Leads (RSLs) and CSSM Systems SMEs.
- Develop targeted training materials/communications with BSOs for implementations and updates.
- Partner with Change Management teams to drive adoption and effective transition.
Process Improvement & Innovation
- Analyze trial workflows for inefficiencies and technology-enabled improvements.
- Support continuous improvement aligned to CSSM and trial execution needs.
- Support innovation pilots and implementation of new digital/system capabilities.
Data Quality & Compliance Support
- Promote high-quality, timely, compliant data entry in clinical systems (e.g., CTMS, eTMF).
- Partner to address data quality issues and ensure adherence to Global Clinical Development procedures.
- Support data monitoring, issue resolution, and compliance readiness.
Stakeholder Engagement & Communication
- Gather feedback and communicate updates with CSSM CoE and trial teams.
- Analyze usage/data/user behavior trends to identify risks and improvements.
- Partner with CSSM CoE communications teams for clear messaging.
Education
- Bachelor’s Degree or equivalent in relevant area
Experience
- 2+ years CSSM (Clinical Sciences and Study Management)
- SME Network Leadership
- Change & Adoption Leadership
Required Skills
- Change Management, Clinical Project Management, CTMS, Clinical Trials Operations, Communication, Cross-Functional Collaboration, Influencing Skills, Process Improvements, Root Cause Analysis (RCA), Stakeholder Management, Training and Development
Application Instructions
- Apply through https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline stated on posting.
- CSSM Systems Lead responsible for representing trial-level operational needs and CSSM business processes in the design, implementation, and ongoing optimization of clinical systems.
- Liaison between CSSM users, Business System Owners (BSOs) and IT to ensure systems support trial execution.
Core Accountabilities and Duties
Trial-Level Business Representation
- Represent CSSM and trial-level user needs in system enhancements, implementations, and ongoing optimization.
- Liaison among CSSM CoE, CSSM users, BSOs, systems SMEs and IT to align technology solutions with trial execution requirements.
- Partner with Global Clinical Development process owners, CSSM CoE and CSSM leadership to support end-to-end trial processes.
User Support & Issue Management
- Build and sustain a CSSM Systems SME network; set support expectations and define escalation paths.
- Point of contact for system inquiries, issues and escalations.
- Collaborate with IT product teams, TOPS, and BSOs to troubleshoot issues and identify root causes.
- Identify recurring challenges and drive improvements via system enhancements and/or process updates.
Training & Change Management
- Design and deliver training programs with CSSM CoE, Regional Systems Leads (RSLs) and CSSM Systems SMEs.
- Develop targeted training materials/communications with BSOs for implementations and updates.
- Partner with Change Management teams to drive adoption and effective transition.
Process Improvement & Innovation
- Analyze trial workflows for inefficiencies and technology-enabled improvements.
- Support continuous improvement aligned to CSSM and trial execution needs.
- Support innovation pilots and implementation of new digital/system capabilities.
Data Quality & Compliance Support
- Promote high-quality, timely, compliant data entry in clinical systems (e.g., CTMS, eTMF).
- Partner to address data quality issues and ensure adherence to Global Clinical Development procedures.
- Support data monitoring, issue resolution, and compliance readiness.
Stakeholder Engagement & Communication
- Gather feedback and communicate updates with CSSM CoE and trial teams.
- Analyze usage/data/user behavior trends to identify risks and improvements.
- Partner with CSSM CoE communications teams for clear messaging.
Education
- Bachelor’s Degree or equivalent in relevant area
Experience
- 2+ years CSSM (Clinical Sciences and Study Management)
- SME Network Leadership
- Change & Adoption Leadership
Required Skills
- Change Management, Clinical Project Management, CTMS, Clinical Trials Operations, Communication, Cross-Functional Collaboration, Influencing Skills, Process Improvements, Root Cause Analysis (RCA), Stakeholder Management, Training and Development
Application Instructions
- Apply through https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline stated on posting.