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Jazz Pharmaceuticals · 1 week ago

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

United States

Full-time

Remote

Senior Level

$135K/yr - $203K/yr

5+ years exp

Jazz Pharmaceuticals is a global biopharma company dedicated to developing life-changing medicines for serious diseases. They are seeking a seasoned Product/System Owner to manage the digital product line supporting Clinical Development Operations, ensuring the optimization of existing systems and the delivery of new technology solutions across the clinical trial lifecycle.

BiotechnologyHealth CarePharmaceutical

No H1B

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

Qualification

Clinical systems managementGxP complianceProduct roadmapsVendor managementAgile methodologiesCommunication skillsProblem-solving skillsOrganizational skills

Required

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

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