Manager, Evidence Generation Data Governance & Systems Lead

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Job Description

Role Objectives:

Support implementation of approved Evidence Generation systems roadmap changes with DD&T and R&D, including requirements coordination, testing support, feedback capture, rollout readiness, training communication, and transition documentation. Maintain implementation discipline, decision logs, backlog updates, dependency tracking, and handoff materials to enable and support the Global Evidence Generation, DD&T, and R&D with systems strategy, prioritization, architecture decisions, and final roadmap direction.

Key Responsibilities:

•       Roadmap Implementation Coordination

•       Convert approved systems roadmap initiatives into implementation actions, milestones, dependencies, owner maps, and status trackers

•       Coordinate implementation planning with DD&T, R&D, Global Evidence Generation, RWD CoE, and affected business users

•       Capture current-state assessment findings, business requirements, backlog inputs, readiness needs, and unresolved dependencies

•       Track implementation progress, open items, testing outcomes, decisions, support fixes, and ad hoc data retrieval needs

•       Testing, Readiness & Change Support

•       Support user acceptance testing, feedback collection, issue tracking, and readiness validation for approved systems changes

•       Coordinate communications on system changes, enhancements, release impacts, training needs, and transition requirements

•       Maintain handoff materials, implementation notes, decision logs, and future upgrade inputs

•       Support updates related to systems such as the Research Module in iEnvision or equivalent Evidence Generation study platforms

•       Governance, Documentation & Escalation

•       Ensure roadmap documentation is version-controlled, traceable, and linked to relevant system, process, and user-impact records

•       Escalate strategy, design, architecture, prioritization, unresolved dependency, or business-impact questions to Global Evidence Generation, DD&T, or R&D owners

•       Identify duplicative requests, unclear backlog ownership, and process gaps that may affect systems implementation quality

•       Support continuous improvement of systems implementation templates, readiness checklists, and communication materials

•        

Qualifications:

Experience: >2 years of related work experience; >2 years of experience in the biopharmaceutical industry; experience in systems implementation, study systems operations, clinical operations technology, evidence generation operations, project coordination, or medical affairs operations preferred

Technical skills:

•       Working knowledge of study execution systems, evidence repositories, data management platforms, or document / contracting systems

•       Ability to translate approved roadmap initiatives into milestones, dependencies, actions, and implementation trackers

•       Familiarity with UAT, release readiness, backlog management, change communication, issue logs, and transition documentation

•       Strong coordination skills across DD&T, R&D, Global Evidence Generation, RWD CoE, and business users

•       Familiarity with iEnvision Research Module, Veeva, eTMF, CTMS, or similar platforms preferred

Education: A scientific, medical, life sciences, technology, data science, public health, operations, or health economics degree is required

Languages: Fluent English required; additional languages advantageous

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