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

Role Summary

Senior Manager, Digital Enterprise Capabilities (DEC) Clinical Systems Operations (Remote) leads the digital product line supporting Clinical Development Operations across the clinical trial lifecycle within Information Services. Accountable for lifecycle management and optimization of existing clinical GxP-compliant systems supporting trial planning, study start-up, execution, data analysis, and study close-out, and for delivering new technology solutions aligned with Clinical capabilities. Collaborates with DEC R&D partners and capability leads to translate strategic priorities into actionable delivery plans and ensures reliable, compliant, and high-performing systems across the Clinical portfolio.

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 business functions, DEC product teams, and external vendors to manage day-to-day system operations and ensure business continuity.
• Own the backlog, execution of change control and validation activities in compliance with Jazz’s GxP, SDLC, and change management standards; ensure seamless coordination with business 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 technology solutions are harmonized with evolving business processes.
• Plan and lead core system ownership responsibilities, including user access reviews, system performance monitoring, upgrade planning, system health checks, disaster recovery testing, and license and vendor contract management.
• Support product roadmapping and release planning by providing input on system enhancement opportunities, business value drivers, and technical feasibility.
• Manage aspects of system operations and smaller-scale projects, including scope definition, resource planning, timelines, and budget tracking in collaboration with product and portfolio teams.
• Ensure alignment with Jazz Quality and Compliance functions to uphold the appropriate level of validation, risk mitigation, and operational control across the system lifecycle.
• Facilitate the 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, system performance monitoring, documentation, and infrastructure planning
• Experience defining and managing product roadmaps, backlogs, KPIs, and SLAs aligned with Clinical business 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 working in a regulated, fast-paced, and 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.
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