Senior Manager, Digital Enterprise Capabilities (DEC) Clinical Systems Operations (Remote)

Role Summary

Senior Manager, Digital Enterprise Capabilities (DEC) Clinical Systems Operations (Remote) responsible for managing the digital product line supporting Clinical Development Operations across the clinical trial lifecycle, ensuring lifecycle management and optimization of GxP-compliant clinical systems, and supporting delivery of new technology solutions aligned with Clinical capabilities.

Responsibilities

• Partner with Clinical Development Operations business capability owners and DEC R&D Business Partners to ensure ongoing alignment, enhancement, and lifecycle management of capability-aligned digital systems supporting key clinical capabilities (e.g., trial planning, CTMS, EDC, site and investigator management).
• Collaborate across Jazz Clinical functions, DEC product teams, and external vendors to manage day-to-day system operations and ensure business continuity.
• Own the backlog, execute change control and validation activities in compliance with GxP, SDLC, and change management standards; coordinate with stakeholders for impact assessments, testing, and rollout.
• Maintain and continuously improve operational system documentation, including validation packages, configuration records, SOPs, and test scripts for both GxP and non-GxP systems.
• Drive issue resolution and technology optimization in partnership with vendors, product managers, and clinical capability leads, ensuring solutions are harmonized with evolving processes.
• Plan and lead core system ownership responsibilities, including user access reviews, system performance monitoring, upgrade planning, health checks, disaster recovery testing, and license/vendor contract management.
• Support product roadmapping and release planning by providing input on system enhancements, business value drivers, and technical feasibility.
• Manage system operations and smaller-scale projects, including scope definition, resource planning, timelines, and budget tracking with product and portfolio teams.
• Ensure alignment with Jazz Quality and Compliance for validation, risk mitigation, and operational control across the system lifecycle.
• Facilitate operationalization of newly implemented systems by collaborating with DEC Business Partners/Capability Leads and ensuring a smooth transition from project delivery to steady-state support.

Qualifications

• Strong working knowledge of Clinical systems including Medidata (e.g., Rave), Veeva Clinical (eTMF, CTMS, CDMS, SSU), and eClinical Solutions, Elluminate or similar clinical data factory.
• Demonstrated expertise in GxP compliance, 21 CFR Part 11, computer systems validation, and Computer Software Assurance (CSA) principles
• Proven ability to manage the full lifecycle of clinical systems, including support operations (Level 2), change control, performance monitoring, documentation, and infrastructure planning
• Experience defining and managing product roadmaps, backlogs, KPIs, and SLAs aligned with Clinical priorities
• Strong vendor management skills, including contract oversight, performance monitoring, and service optimization
• Excellent communication, collaboration, and stakeholder engagement skills; able to work across IT, Quality, and Clinical functions
• Solid understanding of Agile methodologies and experience delivering SaaS-based or cloud-enabled solutions
• Strong problem-solving, analytical, organizational, and follow-up skills with attention to detail
• Experience in a regulated, fast-paced, cross-functional environment supporting clinical development processes

Education

• Bachelor's degree (B.A. or B.S.) from a four-year accredited college or university and 5-7 years of relevant experience; or equivalent combination of education and experience.
• Certified Veeva Clinical Operations Administrator a plus.

Additional Requirements

• Remote work eligibility