BioSpace
Senior Manager, Digital Enterprise Capabilities (DEC) Clinical Systems Operation
BioSpace, Palo Alto, California, United States, 94306
Senior Manager, Digital Enterprise Capabilities (DEC) Clinical Systems Operations (Remote)
Join to apply for the Senior Manager, Digital Enterprise Capabilities (DEC) Clinical Systems Operations (Remote) role at BioSpace. If you are a current Jazz employee, please apply via the Internal Career site.
Jazz Pharmaceuticals is a global biopharma company dedicated to developing life‑changing medicines for serious diseases. The DEC organization seeks a seasoned, delivery‑focused Product/System Owner to manage the digital product line supporting Clinical Development Operations across the clinical trial lifecycle. This role is accountable for the ongoing lifecycle management and optimization of existing GxP‑compliant systems, including trial planning, study start‑up, execution, data analysis, and study close‑out, as well as the delivery of new technology solutions aligned with Clinical capabilities.
Essential Functions
Partner with Clinical Development Operations owners and DEC R&D Business Partners to ensure alignment, enhancement, and lifecycle management of digital systems supporting key clinical capabilities.
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 and execute change control and validation activities in compliance with Jazz’s GxP, SDLC, and change management standards.
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 with vendors, product managers, and clinical capability leads.
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 road‑mapping and release planning by providing input on system enhancements, 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 validation, risk mitigation, and operational control across the system lifecycle.
Facilitate the operationalization of newly implemented systems, collaborating with DEC Business Partners/Capability Leads for 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.
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.
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. For this role, the full and complete base pay range is $135,200.00 – $202,800.00.
#J-18808-Ljbffr
Jazz Pharmaceuticals is a global biopharma company dedicated to developing life‑changing medicines for serious diseases. The DEC organization seeks a seasoned, delivery‑focused Product/System Owner to manage the digital product line supporting Clinical Development Operations across the clinical trial lifecycle. This role is accountable for the ongoing lifecycle management and optimization of existing GxP‑compliant systems, including trial planning, study start‑up, execution, data analysis, and study close‑out, as well as the delivery of new technology solutions aligned with Clinical capabilities.
Essential Functions
Partner with Clinical Development Operations owners and DEC R&D Business Partners to ensure alignment, enhancement, and lifecycle management of digital systems supporting key clinical capabilities.
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 and execute change control and validation activities in compliance with Jazz’s GxP, SDLC, and change management standards.
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 with vendors, product managers, and clinical capability leads.
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 road‑mapping and release planning by providing input on system enhancements, 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 validation, risk mitigation, and operational control across the system lifecycle.
Facilitate the operationalization of newly implemented systems, collaborating with DEC Business Partners/Capability Leads for 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.
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.
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. For this role, the full and complete base pay range is $135,200.00 – $202,800.00.
#J-18808-Ljbffr