EPM Scientific · 2 days ago
Remote Sr Manager DEC Clinical Systems Operations (Veeva)
United States
Full-time
Remote
Senior Level
$150K/yr - $200K/yrEPM Scientific is seeking a seasoned Product/System Owner to lead the digital product line supporting Clinical Development Operations. This role is accountable for the lifecycle management, optimization, and compliance of clinical GxP systems that enable critical capabilities throughout the clinical trial lifecycle.
BiotechnologyRecruiting
Hiring Manager
Adam Kong
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
Qualification
Required
Strong working knowledge of clinical systems such as Medidata Rave, Veeva Clinical (eTMF, CTMS, CDMS, SSU), and platforms like eClinical Solutions/Elluminate
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 Operations Administrator
Benefits
Bonus
Equity
Additional benefits
Company
EPM Scientific
EPM Scientific is proud to be a leading specialist recruitment agency for the life sciences industry.
Founded in 2012
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
S
Sean P.
Senior Vice President Commercial - Field at EPM Scientific
Recent News
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2023-12-23
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