Senior Clinical Systems Implementation Lead

Merck; Rahway (NJ); Vor Ort; USD 130.000 - 180.000; Vollzeit

Zusammenfassung

Merck in Rahway, NJ is seeking a Clinical Systems Implementation Team Lead to drive validation, deployment, and adoption of critical trial applications. You will lead a cross-functional team, ensure SDLC compliance, manage audits, and partner with IT, QA, and clinical operations to deliver reliable systems.

This role requires 2–5 years of people management, deep knowledge of CTMS/EDC/eTMF, and strong communication with senior stakeholders.

Qualifikationen

• BS degree with or above; 10+ years' experience preferred.
• MS/MBA/JD with 8+ years' experience; PhD with 5+ years in related fields.
• Deep understanding of drug development processes and quality management tools.

Aufgaben

• Lead validation, implementation, and adoption of clinical trial applications.
• Ensure SDLC compliance and audit readiness.
• Partner with IT, QA, and business stakeholders to deliver solutions at scale.
• Develop and manage KPIs to measure outcomes and adoption.

Kenntnisse

Clinical Systems Implementation

People Leadership

Cross-Functional Teamwork

Project & Resource Management

Regulatory Compliance

Data Analysis

Communication Skills

GCP/ICH Understanding

Ausbildung

BS degree or higher

MS/MBA/JD or PhD with significant experience

Tools

CTMS

eTMF

EDC System

Clinical Portal

MS Office

Jobbeschreibung

Merck in Rahway, NJ is seeking a Clinical Systems Implementation Team Lead to drive validation, deployment, and adoption of critical trial applications. You will lead a cross-functional team, ensure SDLC compliance, manage audits, and partner with IT, QA, and clinical operations to deliver reliable systems.

This role requires 2–5 years of people management, deep knowledge of CTMS/EDC/eTMF, and strong communication with senior stakeholders.