EPM Scientific

Compensation

Full Description

Sr. Manager, Digital Enterprise Capabilities Clinical Systems Operations - MedRave and Veeva Clinical (Remote) Must be located in the United States to qualify. We're seeking a seasoned, delivery‑focused Product/System Owner to lead the digital product line supporting Clinical Development Operations across the clinical trial lifecycle within Information Services. This role is accountable for the ongoing lifecycle management, optimization, and compliance of clinical GxP systems that enable critical capabilities such as trial planning, study start‑up, execution, data analysis, and study close‑out. In addition, this role will support the delivery and adoption of new technology solutions aligned with evolving Clinical business needs. This is a hands on technical role. The Sr. Manager, DEC Clinical Systems Operations is responsible for ensuring reliable, compliant, and high‑performing clinical digital systems. This role partners closely with the DEC R&D Business Partner, clinical capability owners, Quality, and product delivery teams to translate strategic priorities into executable plans. The position oversees system release planning, change control, validation, vendor management, and inspection readiness, supporting the clinical technology ecosystem throughout the development lifecycle. Key Responsibilities • Partner with Clinical Development Operations and DEC R&D Business Partners to align and manage lifecycle activities for digital clinical systems (e.g., CTMS, EDC, trial planning, site management). • Collaborate across Clinical functions, DEC product teams, and vendors to oversee day‑to‑day system operations and ensure business continuity. • Own and manage the system backlog; lead change control, validation, testing, and release execution in compliance with GxP and SDLC standards. • Maintain and improve system documentation, including validation packages, configuration records, SOPs, and test scripts. • Drive issue resolution and system optimization, ensuring alignment with evolving clinical processes. • Lead core system ownership activities: user access reviews, performance monitoring, upgrades, health checks, disaster recovery testing, and license/vendor management. • Support product roadmapping by contributing insights on enhancements, business value, and technical feasibility. • Manage smaller-scale system projects, including scope, timelines, resources, and budget tracking. • Ensure alignment with Quality and Compliance functions to maintain appropriate validation and operational controls. • Facilitate the transition of new systems into steady‑state operations. Required Knowledge, Skills & Abilities • Must have strong working knowledge of clinical systems both Medidata Rave, Veeva Clinical (eTMF, CTMS, CDMS, SSU), and platforms like eClinical Solutions/Elluminate. • Hands on technical expertise in GxP compliance, 21 CFR Part 11, computer systems validation, and CSA principles. • Proven experience managing full clinical system lifecycles, including Level 2 support, change control, performance monitoring, documentation, and infrastructure planning. • Veeva Clinical Salary: 150,000-210,000 base + bonus + equity + additional benefits