Senior Manager Digital Enterprise Capabilities Clinical Systems Operations

Overview

• Lead digital product lifecycle management for clinical systems, ensuring alignment with strategic priorities and operational excellence.
• Collaborate with cross-functional teams to optimize clinical technology solutions and enhance business processes.
• Ensure compliance with GxP standards, 21 CFR Part 11, and validation requirements for clinical systems.
• Manage vendor relationships, contracts, and system performance to maintain business continuity.
• Support system release planning, change control, and validation activities for clinical capabilities.
• Drive issue resolution and technology optimization for clinical systems in collaboration with stakeholders.
• Facilitate operational transition of newly implemented systems to steady-state support.
• Contribute to product roadmaps and release planning by identifying enhancement opportunities.
• Maintain operational system documentation, including validation packages, SOPs, and test scripts.

Key Responsibilities & Duties

• Collaborate with Clinical Development Operations to align and manage digital systems supporting clinical capabilities.
• Oversee day-to-day system operations, ensuring reliability and compliance with standards.
• Manage change control, validation activities, and system documentation for GxP and non-GxP systems.
• Lead system ownership tasks, including user access reviews, performance monitoring, and disaster recovery testing.
• Drive technology optimization and issue resolution with vendors and product managers.
• Support product roadmapping by providing insights on system enhancements and technical feasibility.
• Ensure alignment with Quality and Compliance functions to maintain operational control.
• Plan and manage smaller-scale projects, including scope definition, resource planning, and budget tracking.
• Facilitate operational readiness for newly implemented systems and ensure smooth transitions.

Job Requirements

• Bachelor's degree in a relevant field or equivalent combination of education and experience.
• 5-7 years of experience in clinical systems management and operations.
• Certified Veeva Clinical Operations Administrator preferred.
• Strong knowledge of Medidata, Veeva Clinical, and eClinical Solutions systems.
• Expertise in GxP compliance, computer systems validation, and CSA principles.
• Proven ability to manage product roadmaps, KPIs, and SLAs aligned with business priorities.
• Excellent vendor management skills and stakeholder engagement capabilities.
• Experience delivering SaaS-based solutions using Agile methodologies.
• Strong analytical, organizational, and problem-solving skills with attention to detail.