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

BioSpace; Palo Alto (CA); Remote; USD 135,200 - 202,800; Full time

Benefits offered by this job

Discretionary annual cash bonus

Comprehensive benefits offering

Flexible paid vacation

Job summary

A leading biopharma company is seeking a Senior Manager, Digital Enterprise Capabilities to oversee clinical systems operations. This remote role involves managing clinical GxP-compliant systems across the trial lifecycle, ensuring alignment with business capabilities, and collaborating closely with a diverse team to deliver optimal technology solutions. Candidates should have strong clinical systems knowledge, exceptional vendor management skills, and a minimum of 5-7 years of relevant experience. The annual compensation range is $135,200 to $202,800, depending on qualifications.

Qualifications

• 5-7 years of relevant experience in clinical systems management.
• Experience in system performance monitoring and documentation.
• Ability to manage product roadmaps and backlogs.

Responsibilities

• Manage digital product line supporting Clinical Development Operations.
• Ensure lifecycle management and optimization of clinical GxP-compliant systems.
• Collaborate with business capability owners for system alignment.

Skills

Strong working knowledge of Clinical systems including Medidata

GxP compliance

Vendor management skills

Excellent communication skills

Solid understanding of Agile methodologies

Education

Bachelor's degree from an accredited college

Tools

Medidata Rave

Veeva Clinical

Job description

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

3 days ago Be among the first 25 applicants

If you are a current Jazz employee please apply via the Internal Career site.

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate 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. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit https://www.jazzpharmaceuticals.com for more information.

Jazz Pharmaceuticals’ Digital Enterprise Capabilities (DEC) organization is seeking a seasoned and delivery-focused Product/System Owner to manage the digital product line supporting Clinical Development Operations across the clinical trial lifecycle, within 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 close-out. In addition, this role will support the delivery of new technology solutions aligned 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 Lead) – 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 convert 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 excellence. This role is critical to advancing Jazz’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-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.

Required Knowledge, Skills, And Abilities

• 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

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 Veeva Clinical Operations Administrator a plus.
• #remote

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

FOR US BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $135,200.00 - $202,800.00

Individual compensation paid within this range 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 aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

At Jazz, your base 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 Jazz'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 vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click https://careers.jazzpharma.com/benefits.html.