Associate Director, CSSM Systems Lead, Hybrid
Merck
June 29, 2026
Remote friendly (Upper Gwynedd, PA)
United States
IT
Position Description
- The CSSM Systems Lead represents trial-level operational needs and CSSM business processes in the design, implementation, and ongoing optimization of clinical systems, serving as a key liaison between CSSM users, Business System Owners (BSOs), and IT to ensure systems support trial execution.
Responsibilities / Core Accountabilities and Duties
- Trial-Level Business Representation: Represent CSSM and trial-level user needs in system enhancements, implementations, and optimization; liaison between CSSM CoE, CSSM users, BSOs, system SMEs, and IT; partner with Global Clinical Development process owners, CSSM CoE, and CSSM leadership to support end-to-end trial processes.
- User Support & Issue Management: Build/sustain a CSSM Systems SME network; define support expectations and escalation pathways; serve as point of contact for system inquiries/escalations; troubleshoot with IT product/TOPS/BSOs to identify root causes; drive improvements via enhancements and/or process updates.
- Training & Change Management: Design/deliver training with CSSM CoE, Regional Systems Leads, and CSSM Systems SMEs; develop targeted training materials/communications with BSOs; partner with Change Management teams to drive adoption.
- Process Improvement & Innovation: Analyze workflows to find inefficiencies; support continuous improvement; support innovation pilots and implementation of new digital/system capabilities.
- Data Quality & Compliance Support: Promote timely, compliant data entry (e.g., CTMS, eTMF); address data quality with RSLs/CSSM SMEs/DIA; support data monitoring, issue resolution, and compliance readiness.
- Stakeholder Engagement & Communication: Gather feedback, communicate updates; analyze usage/data/user behavior trends; partner with 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, 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.
Application
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.
- The CSSM Systems Lead represents trial-level operational needs and CSSM business processes in the design, implementation, and ongoing optimization of clinical systems, serving as a key liaison between CSSM users, Business System Owners (BSOs), and IT to ensure systems support trial execution.
Responsibilities / Core Accountabilities and Duties
- Trial-Level Business Representation: Represent CSSM and trial-level user needs in system enhancements, implementations, and optimization; liaison between CSSM CoE, CSSM users, BSOs, system SMEs, and IT; partner with Global Clinical Development process owners, CSSM CoE, and CSSM leadership to support end-to-end trial processes.
- User Support & Issue Management: Build/sustain a CSSM Systems SME network; define support expectations and escalation pathways; serve as point of contact for system inquiries/escalations; troubleshoot with IT product/TOPS/BSOs to identify root causes; drive improvements via enhancements and/or process updates.
- Training & Change Management: Design/deliver training with CSSM CoE, Regional Systems Leads, and CSSM Systems SMEs; develop targeted training materials/communications with BSOs; partner with Change Management teams to drive adoption.
- Process Improvement & Innovation: Analyze workflows to find inefficiencies; support continuous improvement; support innovation pilots and implementation of new digital/system capabilities.
- Data Quality & Compliance Support: Promote timely, compliant data entry (e.g., CTMS, eTMF); address data quality with RSLs/CSSM SMEs/DIA; support data monitoring, issue resolution, and compliance readiness.
- Stakeholder Engagement & Communication: Gather feedback, communicate updates; analyze usage/data/user behavior trends; partner with 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, 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.
Application
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.