Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to
advancements across our robust pipeline of innovative therapeutics in oncology and
laboratories, manufacturing facilities and employees in multiple countries committed to
serving patients worldwide. The Business & Technology Capabilities (B&TC) Sr. Analyst works closely with B&TC and GCDO colleagues, in collaboration with Information Services (IS) to support cross functional clinical study teams regarding the implementation and management of digital systems/technology used by GCDO including but not limited to Veeva Clinical Vault. Analyst demonstrates a good understanding of Veeva Clinical Vault functionality. Analyst works with the ‘Performance and Training’ function to facilitate the collation, visualization, analysis & storage of relevant metrics for GCDO to ensure optimal trial performance and aid continuous improvement
Establishes and maintains, digital systems on behalf of GCDO primarily the Veeva Clinical Vault applications eTMF, CTMS, SSU and Site Connect, plus other Clinical Systems as required
Works closely with Business owners and system owners of digital system including but not limited to Veeva Clinical Vault, to ensure GCDO teams are trained appropriately in the functionality of relevant digital systems
Collaborates with other functional areas/departments and key stakeholders to maximize the utilization of the digital systems (e.g. creating dashboards, reports, ensuring best use of all Clinical Vault functionality
Collaborates with subject matter experts on development of relevant digital system training materials, QMS documentation, and Validation activities and documentation
Establishes and maintains, digital systems on behalf of GCDO primarily the Veeva Clinical Vault applications eTMF, CTMS, SSU and Site Connect, plus other Clinical Systems as required
~ Works closely with Business owners and system owners of digital system including but not limited to Veeva Clinical Vault, to ensure GCDO teams are trained appropriately in the functionality of relevant digital systems
~ Collaborates with other functional areas/departments and key stakeholders to maximize the utilization of the digital systems (e.g. creating dashboards, reports, ensuring best use of all Clinical Vault functionality
~ Collaborates with subject matter experts on development of relevant digital system training materials, QMS documentation, and Validation activities and documentation
~ Identifies improvement opportunities related to digital systems, and assists with developing enhancement plans and roadmaps
~ Organizes and delivers relevant specialist training sessions and workshops with a key focus on digital systems
~ IT-literate and passionate/experienced towards new technology and digital systems including, but not limited to Microsoft-based applications and Veeva Clinical Vault applications CTMS, eTMF, SSU and Site Connect
~ An experienced clinical trials professional who is well versed in the field of clinical study management activities, combined with excellent project management, training & mentoring capabilities
~ Previous experience working in Veeva Clinical Vault as an end user, business, or system administrator
~ Ability to effectively interface with CROs and software vendor
~ Previous experience working in clinical trials, with emphasis on GxP and compliance
~ Has a sound working knowledge of clinical operations, clinical processes, Trial Master File regulations medical terminology, global CROs and vendor management
~ Quality driven with a focus on attention to detail
~ Flexible approach with respect to work assignments and new learning
~ A minimum of a BA/BS, preferably in the scientific/healthcare and/or technology field
~ A minimum of 5 years of experience in clinical related technology for the pharmaceutical/biotechnology industry
~ Knowledge of FDA/ICH guidelines and industry standard practices regarding the management of clinical trial data and studies.
~ Computerized Systems Used in Clinical Trials, General Principles of Software Validation.
~ 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.
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. 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. 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.