Clinical Systems Implementation Leader

Merck; North Wales (Montgomery County); On-site; USD 120,000 - 180,000; Full time

Job summary

Merck is seeking an experienced Clinical Systems Implementation Team Lead to drive validation, implementation, and adoption of trials support applications. The role partners with GCD, IT and vendors to deliver compliant, scalable solutions with strong data governance and SDLC adherence.

You will lead a team, mentor staff, and ensure training, audits, and KPI tracking are in place while advancing the technology roadmap for clinical operations and patient experience improvements.

Qualifications

• Must have 2–5 years of people management experience.
• Broad understanding of drug development, safety, regulatory, ICH and GCP requirements.
• Ability to quickly gain subject matter expertise in a new business area as needed.
• Strong verbal and written communication skills, able to present confidential information to leadership and teams.
• Ability to interact with management at all levels and influence results without formal authority.

Responsibilities

• Lead the Clinical Systems Implementation team in validation, implementation and operation of clinical trial applications.
• Partner with cross-functional SMEs and IT to identify innovative solutions and drive adoption.
• Monitor technology trends and map capabilities to business requirements within GCTO strategy.
• Create business cases for innovation and manage pilots to scale successful solutions.
• Ensure audit readiness and compliance with SDLC, governance, and training requirements.
• Oversee team resourcing, performance reviews, and succession planning.

Skills

People management

Drug development

Subject matter expert

Communication skills

Stakeholder management

Project management

Clinical trial processes

CTMS

eTMF

EDC

Clinical portal

MS Office

Education

BS degree

MS/MBA/JD or PhD

Job description

Merck is seeking an experienced Clinical Systems Implementation Team Lead to drive validation, implementation, and adoption of trials support applications. The role partners with GCD, IT and vendors to deliver compliant, scalable solutions with strong data governance and SDLC adherence.

You will lead a team, mentor staff, and ensure training, audits, and KPI tracking are in place while advancing the technology roadmap for clinical operations and patient experience improvements.