Engagement Lead / Program Manager , Clinical Systems (UAT)

Job Overview

We are seeking an experienced Engagement Lead / Program Manager to lead testing and implementation support for a new Risk-Based Quality Management (RBQM) system within Clinical Operations.

The Engagement Lead will oversee a team of Technical Analysts and serve as the central point of coordination for UAT and testing activities throughout the implementation. This individual will work closely with the Business System Owner, business SMEs, IT, Quality/Validation teams, and the technology vendor to ensure requirements are understood, testing is effectively planned and executed, issues are resolved, and key implementation milestones remain on track.

This is a fast-moving implementation with aggressive timelines, requiring a hands-on leader who can bring structure to the testing workstream, proactively manage dependencies and risks, and drive activities through completion.

Deep RBQM expertise is not required. The ideal candidate will have strong experience supporting GxP-regulated systems, leading UAT and validation activities, and managing complex system implementations within Life Sciences.

Responsibilities

• Serve as the primary lead for the UAT and testing workstream, coordinating activities across the Business System Owner, business SMEs, IT, Quality/Validation teams, vendor teams, and Atlas Technical Analysts.

• Participate in requirements, business process, and system design/configuration sessions to develop a strong understanding of intended functionality and business use cases.

• Translate project requirements and business use cases into an overall UAT strategy, test plan, priorities, and execution schedule.

• Lead and provide direction to Technical Analysts responsible for developing test cases/scripts, executing testing, documenting results, and supporting defect resolution.

• Define and manage testing milestones, dependencies, resource assignments, deliverables, and reporting cadence in alignment with the broader implementation plan.

• Plan and coordinate UAT and associated SDLC/validation documentation in accordance with GxP requirements and the project Quality Assurance Plan.

• Ensure appropriate requirements traceability and testing coverage throughout the implementation lifecycle.

• Coordinate test readiness activities and ensure business SMEs and testers are prepared for scheduled testing cycles.

• Lead UAT status reporting, including test case development and execution progress, resource assignments, timelines, metrics, issues, and risks.

• Coordinate defect triage and drive issues through resolution in partnership with business, technical, quality, and vendor teams.

• Identify project risks, dependencies, and potential timeline impacts early and escalate appropriately.

• Provide regular status updates to project leadership and key stakeholders, maintaining clear visibility into progress, risks, decisions, and upcoming milestones.

• Support knowledge transfer and ensure the project team develops sufficient understanding of the system and business processes throughout requirements and implementation.

• Support technical go-live, business go-live, integration activities, release readiness, and post-implementation activities as required.

• Guide and mentor Technical Analysts, remove roadblocks, and ensure consistent quality across testing and project deliverables.

• Support business process updates, change management, training, and other implementation activities as needed.

Qualifications

• 8+ years of experience supporting clinical, GxP-regulated, or other validated systems within the Life Sciences industry.

• Demonstrated experience leading complex system implementations, UAT programs, or testing workstreams.

• Strong understanding of GxP system validation, Computer System Validation (CSV), SDLC processes, UAT, requirements traceability, and controlled documentation.

• Experience translating business and system requirements into structured testing strategies and execution plans.

• Proven ability to lead analysts and coordinate across business, IT, Quality/Validation, and vendor teams.

• Strong project/program management skills with experience managing aggressive timelines, competing priorities, dependencies, risks, and escalations.

• Experience supporting clinical operations technology or clinical development systems strongly preferred.

• RBQM or risk-based monitoring experience is a plus but not required.

• Excellent communication, organization, stakeholder management, and problem-solving skills.

Job Overview:
We are seeking an Engagement Lead to oversee delivery, design, configurations testing across two Clinical Operations initiatives. The two initiatives include Veeva Study training and Veeva Clinical Site Connect and feasibility. The ideal Engagement Lead will have a specific background in Veeva Vault, including Veeva Clinical, CTMS, SSU and TMF modules and experience leading teams to execute on this work.
This role will lead a team of Analysts and Technical Analysts responsible for Non-Protocol Specific Training, Protocol Specific Training for Site users (replacing Clients Clinical Management System) and Sponsors (replacing Clients E-Learning courses). Additionally, the team will support Document Exchange, Feasibility, Safety reporting, & Study Announcements capabilities. The ideal candidate will demonstrate both strong program leadership and deep understanding of clinical systems and validation practices. Responsibilities:

• Serve as the central point of coordination between Product Owner, Module Leads, Business SME's, BA Team & Quality & Engineering (QE) Team (responsible for Automated testing) to plan and ensure the effective and timely execution of UAT activities.
• Attend business process and system configuration workshops/meetings to gain understanding of the system and functionality being designed.
• Conduct Alpha and Beta reviews of configurations (dry run testing) along with system owner and business SMEs
• Define and manage the overall delivery roadmap, project milestones, and reporting cadence for ongoing business systems support.
• Plan and manage conduct of UAT and associated SDLC documentation in alignment with the documented Quality Assurance Plan (QAP).
• Provide strategic oversight of testing and validation efforts, including UAT coordination, requirements traceability, and release readiness.
• Serve as the subject matter advisers on user stories & expected functionality and provide ongoing guidance to the BA Team (as necessary)
• Coordinate the reporting of UAT status for both solutions with QE Test Lead (# of test scripts, who is assigned, status, timelines, metrics, issues tracking).
• Co-lead defect triage process with QE Test Lead.
• Drive collaboration across teams to identify and resolve issues quickly, escalate risks, and maintain transparent communication with stakeholders.
• Develop and provide regular status reports to Clin Ops Leadership & Veeva Clinical Product Owners.
• Provide guidance on KT sessions led by BA team with QE Testers
• Assists with system implementation tasks as required
• Support business process update and change management & training activities
• Guide and mentor team members—providing direction, removing roadblocks, and ensuring consistent quality across deliverables.
• Support process optimization and change management activities related to new systems and workflows.

Qualifications:

• 8+ years of experience in Clinical Operations systems, business systems management, or validation oversight.
• Strong background in project and program leadership within a regulated Life Sciences environment.
• Strong understanding of system validation (CSV), UAT processes, and business process analysis.
• Excellent communication, organizational, and problem-solving skills.

Join Our Team at Atlas
Atlas is a global strategic consulting firm, focused on the Life Sciences industry. Our services include Management Consulting, Managed Services and Agile Services. Global pharmaceutical companies and emerging players in life sciences depend on Atlas consultants to ensure they have the capabilities that will give them the ability to succeed. We are seeking Atlas IMPACT Makers who are ready to lead and innovate in dynamic environments. IMPACT Makers embody the principles of Atlas, driving transformative change and delivering outstanding results.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, genetics, disability, age, or veteran status. We value diversity and inclusion in our workplace and are committed to creating an environment where everyone has an equal opportunity to succeed