Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical 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 and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

This Job Description provides a summary of the duties and/or characteristic of work performed and is not inclusive of every detail of the job for every individual assigned to the position. This description will be reviewed periodically and revised as duties and responsibilities change with business demands. Other duties not listed above may be assigned as needed.

Brief Description:

The Senior Clinical Data Manager will be responsible for performing Data Management activities that support Jazz Pharmaceuticals’ commercial and development projects worldwide. He/she will participate as an active member of a multi-disciplinary team to plan, lead and execute the Data Management tasks required for phase 1-4 studies. The Senior Clinical Data Manager has a broad, fundamental knowledge of the data management process and can perform most required tasks with minimal guidance.

Essential Functions

The Senior Clinical Data Manager will:

• Be able to lead a large clinical study or a series of related studies with minimal guidance
• Represent Data Management on the CTWG for assigned studies
• Provide mentoring and training to lower-level Data Management staff assigned to his/her studies
• Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts
• Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
• Perform a thoroughly detailed review of eCRF data requirements.
• Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
• Lead the development of data edit check specifications and data listings
• Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members
• Develop or lead the development of the Data Management Plan for a clinical study.
• Review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications
• May provide training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed
• Perform reconciliation of header data from external data sources against the clinical database
• Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
• Lead database upgrades/migrations including performing User Acceptance Testing
• Be able to maintain study workbooks and data management files
• Perform database lock and freeze activities per company SOPs
• Participate in regular team meetings and provide input when appropriate
• Provide input into the development of data management SOPs, Work Instructions, and process documents; take a leadership role in the development of assigned documents
• Contribute to a professional working environment including the application of Jazz Pharmaceuticals Code of Business Conduct and Ethics
• Assist with the training of new employees and/or contractors

Required Knowledge, Skills, and Abilities

• At least five years’ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience
• Strong project management skills and a proven ability to multitask
• Understands the scope and focus of Phase 1-4 clinical studies and has a proven ability to perform most of the core Data Management tasks and interact with vendors.
• Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Possesses strong English language written and verbal communication skills.
• Experience and understanding of the Oncology or CNS therapeutic area, and with Phase III pivotal studies are preferred.
• Able to travel to off-site meetings or training seminars as needed.
• Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable.

Required/Preferred Education and Licenses

• Bachelor’s Degree required (Master's Degree preferred) in the scientific/healthcare field.

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 anticipated base pay range is $112,000-$147,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience.

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: https://careers.jazzpharma.com/benefits