Clinical Systems Implementation Lead, SDLC & Compliance

MSD; North Wales (Montgomery County); Hybrid; USD 173,000 - 273,000; Full time

Job summary

Merck & Co., Inc. in the USA (Pennsylvania, North Wales) seeks a Clinical Systems Implementation Team Lead to drive validation, implementation and adoption of clinical trial applications. The role combines team leadership with audits, data governance and SDLC compliance across GCD/IT partners.

The ideal candidate will mentor staff, manage resources, and ensure quality delivers while advancing the technology roadmap in a global, regulated environment.

Qualifications

• Two to five years of people management experience is required.
• Broad understanding of drug development – safety, clinical trials, trial design, data management, trial operations, regulatory, privacy, ICH, and GCP.
• Ability to quickly gain subject matter expertise in a new business area.

Responsibilities

• Partner with SMEs and IT to assess business needs and identify solutions.
• Ensure SDLC compliance and audit readiness for validated systems.
• Lead or participate in cross-functional technology initiatives and governance.
• Develop change management and communication plans for adoption of technology.

Skills

Adaptability

Benchmarking

Business Process Re-Engineering

Clinical Systems Implementation

Cross-Functional Teamwork

Data Analysis Tools

Decision Making

GMP

Innovation

IT Implementation

People Leadership

Professional Integrity

Quality Control Management

Risk Management

Strategic Planning

Education

BS degree with or above

MS/MBA/JD

PhD

Job description

Merck & Co., Inc. in the USA (Pennsylvania, North Wales) seeks a Clinical Systems Implementation Team Lead to drive validation, implementation and adoption of clinical trial applications. The role combines team leadership with audits, data governance and SDLC compliance across GCD/IT partners.

The ideal candidate will mentor staff, manage resources, and ensure quality delivers while advancing the technology roadmap in a global, regulated environment.