Manager, Clinical Data Innovation

Jazz Pharmaceuticals; Philadelphia (Philadelphia County); Remote; USD 124,000 - 186,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k retirement savings plan

Flexible paid vacation

Job summary

Jazz Pharmaceuticals, Inc. is seeking a Manager, Clinical Data Innovation to lead the implementation of our centralized clinical data platform, enabling oversight, medical monitoring, and efficient data review across studies.

You will drive platform adoption, collaborate with trial teams and vendors, and advance automated data flows, dashboards, and risk-based quality management within a GxP framework.

Qualifications

• Bachelor or Master's degree in Biology, Mathematics, Computer Science or related fields.
• 3-5+ years of relevant work experience in clinical trial execution and/or clinical systems implementation.
• Experience with R, Python, or QlikSense for data analysis.
• Strong communication and collaboration skills across cross-functional teams.

Responsibilities

• Lead the end-to-end implementation of clinical studies on the clinical data platform, including vendor RFP review, data imports, user acceptance testing, and delivery of standard and custom listings and visualizations.
• Develop relationships with cross-functional trial teams to leverage the platform for data review, medical monitoring, and risk management plans.
• Contribute to software systems and infrastructure to display study data and metrics.
• Collaborate with external vendors and data managers to automate data acquisition into the platform.
• Champion adoption of best practices and continuous improvement within Clinical Data Innovation.

Job description

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 www.jazzpharmaceuticals.com for more information.

The 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/Responsibilities

• Lead the implementation of new processes and technologies used to review and trend clinical trial data during study conduct
• Lead 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 visualizations
• Develops 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 plans
• Contribute to the development of software systems and related infrastructure to generate displays of clinical study data and metrics reports that are efficient and user-friendly
• Collaborate with external vendors and data managers to automate the acquisition of all clinical data into the platform
• Cultivate 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 processes

May additionally perform the following functions:

• Program visualizations that provide visibility into start-up and conduct of clinical trials using QlikSense
• Configure and program methods for centralized monitoring of data to support risk-based quality management

• Support the continued development of the clinical data platform, including software updates, and ensure that deliverables adhere to system user requirements and GxP requirements

Required Knowledge, Skills, and Abilities

• In-depth knowledge of clinical trial planning, start-up, and conduct concepts and challenges that can be supported using data visualizations
• Excellent verbal and written communication skills, specifically in communicating technical concepts to non-technical individuals and communicating business requirements to technical programmers
• Strong problem-solving skills with an emphasis on clinical data
• Strong problem-solving skills with an emphasis on solving technical and data problems
• Experience with requirements elicitation and documentation for dashboards, reports, or data review listings using agile methodologies/principles
• Ability to prioritize and handle multiple tasks simultaneously in a cross-functional team environment
• In depth understanding of regulatory, industry (GCP), and technology standards and requirements [ICH E6 and Regulatory Guidelines and SDLC
• Experience with elluminate platform is a plus
• Experience with advanced analytics (machine learning methods) applied to clinical trials is a plus
• Experience with T-SQL, QlikSense, R, or Python is a plus
• Knowledge of ICH E6 (R2) Risk Based Quality Management a plus
• Experience supporting or performing centralized statistical monitoring a plus
• Jazz values are Passion, Innovation, Collaboration and Integrity and Pursuit of Excellence! This is highly valued in our employees.

Required/Preferred Education and Licenses

• Bachelor or Master's Degree in Biology, Mathematics, Computer Science or related fields

• 3-5+ years of relevant work experience, such as clinical trial execution and/or clinical systems implementation.

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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: $124,000.00 - $186,000.00

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.

• medical insurance
• dental insurance
• vision insurance
• 401k retirement savings plan
• flexible paid vacation

For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html.