Manager, Clinical Data Innovation

If you are a current Jazz employee please apply via the Internal Career siteJazz 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 for more information.Job DescriptionThe Manager, Clinical Data Innovation within the GCDO Business & Technology Capabilities department is responsible for the implementation of clinical studies on Jazz’s centralized clinical data platform and adoption of the platform by study teams to achieve oversight, medical monitoring, clinical data review, and risk-based quality management objectives. We are looking for a creative, curious individual who thrives on problem solving and is motivated by the goal of transforming clinical trial execution through practical applications of data and technology to increase automation, efficiency, and quality. S/he will be a subject matter expert on the clinical data platform, responsible for implementation of new studies and acting as an advisor to clinical trial working groups on using the interactive data listings and analytics to continuously improve clinical trial start-up and conduct. S/he will also participate on departmental and cross-functional initiatives to assess and implement new technologies to innovate and transform clinical trial execution. Essential Functions/ResponsibilitiesLead the implementation of new processes and technologies used to review and trend clinical trial data during study conductLead the end-to-end implementation of clinical studies on the clinical data platform, including vendor RFP review, data imports, user accepting testing, and delivery of standard and custom listings and visualizationsDevelops strong relationships with the cross functional clinical trial working group team to proactively advise on how to use the clinical data platform to achieve objectives defined in functional plans such as data review plans, medical monitoring plans, and/or risk management plansContribute to the development of software systems and related infrastructure to generate displays of clinical study data and metrics reports that are efficient and user-friendlyCollaborate with external vendors and data managers to automate the acquisition of all clinical data into the platformCultivate and disseminate knowledge of application-usage best practices, identifying and implementing solutions to facilitate comprehensive adoption and effectiveness of the clinical data platform Identify and implement continuous improvement initiatives for Clinical Data Innovation team processesMay additionally perform the following functions:Program visualizations that provide visibility into start-up and conduct of clinical trials using QlikSenseConfigure and program methods for centralized monitoring of data to support risk-based quality managementSupport the continued development of the clinical data platform, including software updates, and ensure that deliverables adhere to system user requirements and GxP requirementsRequired Knowledge, Skills, and AbilitiesIn-depth knowledge of clinical trial planning, start-up, and conduct concepts and challenges that can be supported using data visualizationsExcellent verbal and written communication skills, specifically in communicating technical concepts to non-technical individuals and communicating business requirements to technical programmersStrong problem-solving skills with an emphasis on clinical dataStrong problem-solving skills with an emphasis on solving technical and data problemsExperience with requirements elicitation and documentation for dashboards, reports, or data review listings using agile methodologies/principlesAbility to prioritize and handle multiple tasks simultaneously in a cross-functional team environmentIn depth understanding of regulatory, industry (GCP), and technology standards and requirements [ICH E6 and Regulatory Guidelines and SDLCExperience with elluminate platform is a plusExperience with advanced analytics (machine learning methods) applied to clinical trials is a plusExperience with T-SQL, QlikSense, R, or Python is a plusKnowledge of ICH E6 (R2) Risk Based Quality Management a plusExperience supporting or performing centralized statistical monitoring a plusJazz values are Passion, Innovation, Collaboration and Integrity and Pursuit of Excellence! This is highly valued in our employees.Required/Preferred Education and LicensesBachelor or Master's Degree in Biology, Mathematics, Computer Science or related fields3-5+ years of relevant work experience, such as clinical trial execution and/or clinical systems implementation.#LI-DM1#LI-RemoteJazz 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 ONLYJazz 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:$124,000.00 - $186,000.00Individual 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 here:SummaryLocation: US - Home-Based; Philadelphia, Pennsylvania; Palo Alto, CaliforniaType: Full time