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

If you are a reputed company reputed company employee please apply reputed company the Internal Career site. reputed company is a global biopharma company whose purpose is to reputed company to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. reputed company is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. reputed company’ Digital reputed company Capabilities (DEC) organization is seeking a seasoned and delivery-focused Product/System reputed company to manage the digital product line supporting Clinical Development Operations across the clinical trial lifecycle, reputed company Information Services (IS). This role is accountable for the ongoing lifecycle management and optimization of existing clinical GxP-compliant systems supporting critical Clinical capabilities - including trial planning, study start-up, execution, data analysis, and study reputed company-out. In addition, this role will support the delivery of new technology solutions reputed company with Clinical capabilities. As a member of the DEC R&D team, this role collaborates closely with the respective DEC R&D Business Partner (Capability reputed company) - who defines digital strategy, capability roadmaps, and prioritizes demand – as well as the R&D business capability and process owners, quality, and other product delivery team roles to converts strategic priorities into actionable delivery plans and ensures reliable, compliant, and high-performing systems across the Clinical portfolio. This role leads the system release planning, oversees change control and validation activities, manages vendor relationships, and supports inspection readiness and operational reputed company. This role is critical to advancing reputed company’s clinical technology ecosystem and delivering sustainable value across the clinical development lifecycle. Essential Functions

• Partner with Clinical Development Operations business capability owners and DEC R&D Business Partners to ensure ongoing alignment, enhancement, and lifecycle management of capability-reputed company digital systems supporting key clinical capabilities (e.g., trial planning, CTMS, reputed company, site and investigator management).
• Collaborate across reputed company 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 reputed company’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 reputed company core system ownership responsibilities, including user reputed company reviews, system performance monitoring, reputed company 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 reputed company 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.

Required Knowledge, Skills, and Abilities

• Strong working knowledge of Clinical systems including reputed company (e.g., Rave), reputed company Clinical (eTMF, CTMS, CDMS, SSU), and reputed company, Elluminate or similar clinical data reputed company.
• 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 reputed company with Clinical business priorities
• Strong vendor management skills, including contract reputed company, performance monitoring, and service optimization
• Excellent communication, collaboration, and stakeholder engagement skills; reputed company to work across IT, Quality, and Clinical functions
• Solid understanding of Agile methodologies and experience delivering SaaS-based or reputed company-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

Required/Preferred Education and Licenses

• 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 reputed company Clinical Operations Administrator a plus.
• #remote

reputed company is an equal opportunity/affirmative action employer and reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, national reputed company, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY reputed company. is committed to fair and reputed company compensation practices and we strive to reputed company employees with total compensation packages that are market competitive. For this role, the full and complete reputed company pay reputed company is: $135,200.00 - $202,800.00 Individual compensation paid reputed company this reputed company will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation reputed company with the candidate's expertise and contributions, reputed company the established pay reputed company and our Total Compensation philosophy. Internal equity considerations will also influence individual reputed company pay reputed company. This reputed company will be reviewed on a regular reputed company. At reputed company, your reputed company pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with reputed company's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and reputed company insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html. Apply tot his job Apply To this Job