Clinical Systems Implementation Team Lead

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

Job summary

Merck & Co. is seeking a Clinical Systems Implementation Team Lead to oversee the validation, implementation, and adoption of clinical trial applications across internal and external platforms.

You will lead a team, ensure SDLC compliance, and collaborate with Global Clinical Development IT and vendors to deliver quality solutions. The role includes staff leadership, training alignment, and participation in leadership activities to drive program success and audit readiness within the R&D IT

Responsibilities

• Partner with cross-functional SMEs and end-users to assess emerging business needs and identify innovative solutions with GCD IT.
• Monitor technology trends and map capabilities to requirements to enable business processes aligned with GCTO strategy.
• Develop high-impact business cases for innovation and advance solutions from concept to pilot and implementation, ensuring due diligence and audit readiness.

Job description

Job Description

Clinical Systems Implementation Team Lead within BEO manages the full range of activities related to the successful validation, implementation, and adoption of applications that support our company's clinical trials. These systems can be internally and/or externally facing, large or small, vendor or company developed and owned. The role also has people management responsibility for team members supporting similar activities.

The team lead should have needed experience and knowledge related to the systems and processes being supported by the team or prioritize gaining this experience once in the role. Partner with various business areas within Global Clinical Development (GCD), with our Research & Development Division –IT and vendors to understand business needs, identify solutions to support those needs and implement solutions with quality focus. The role ensures compliance to company policies, agency regulations and related guidance around technology and applies data stewardship and data governance principles in the management of the applications.

Accountable for supporting systems audits and inspections and follow-up of any findings and required CAPA management. Ensure systems quality lead is engaged early in process of upgrading or re-platforming of technology to ensure proper SDLC compliance. Ensure Clinical Systems Implementation team members are properly trained on SDLC requirements and maintain their training. As part of the BEO Leadership Team, identify topics and appropriate guest speakers for monthly department meeting agenda, propose projects/assignment for interns and support activities to identify appropriate candidates for internship, and schedule quarterly business review meetings to share team accomplishments and upcoming activities with other team leads.

Responsibilities

• Partner with a cross-functional team of functional SMEs and end-users to independently assess emerging business needs and work with our Research & Development Division –IT to identify innovative solutions to meet the need.
• Monitor technology trends to match the business needs, profile partners and vendors and map capabilities to requirements to enable business processes in alignment with the GCTO strategy.
• Partner with various business functional stakeholders and our Research & Development Division –IT and create high-impact & high-value business cases for innovation opportunities and advance selected solutions from proof of concept to pilot and implementation at scale, ensuring required due diligence has been carried out, and the solution is audit/inspection ready, if applicable.