Senior Clinical Data Manager in Newtownabbey

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.

The Senior Clinical Data Manager will be responsible for performing Data Management activities that support Jazz Pharmaceuticals’ commercial and development projects worldwide. You 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 is able to perform most required tasks with minimal guidance.

• Represent Data Management on the study team for assigned studies.
• Manage and monitor the progress of data management activities and vendors on assigned studies.
• Manage and monitor CRO progress for outsourced studies.
• Build effective relationships with CRO/vendor counterparts.
• Review protocols for appropriate data capture requirements including electronic Case Report Form (eCRF) design and electronic Clinical Outcome Assessments (eCOA) forms.
• Interact with study team members e.g., CRAs, programmers, CTMs and statisticians in designing eCRFs and CRF completion guidelines.
• Lead the design and testing of Electronic Data Capture (EDC) systems according to company standards.
• Able to resolve EDC system issues with team members.
• Support the development of other system set-up e.g., eCOA and Interactive Response Technology (IRT).
• Lead the development of data edit check specifications and data listings and run data listings as required.
• Develop or lead the development of the Data Management documents for a clinical study.
• Able to review and provide feedback to the clinical team on other study documents e.g., Clinical Monitoring plans, Statistical analysis plans and vendor specifications.
• Provide training on the EDC and/or eCOA system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed.
• Lead database upgrades/migrations including performing User Acceptance Testing.
• Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries.
• Perform reconciliation of data from external data sources against the clinical database.
• Perform Serious Adverse Event reconciliation activities.
• Perform database freeze and lock activities.
• Be able to maintain study eTMF.
• Participate in the generation of study timelines and manage DM activities against the timelines.
• Provide mentoring and training to junior level Data Management staff assigned to his/her studies.
• Assist with the onboarding and/or training of new employees and/or contractors.
• Participate in regular Clinical Data Operations team meetings and provide input when appropriate.
• Contribute to or lead department process improvement initiatives which could include the development of data management SOPs, Work Instructions, and process documents.
• Contribute to a professional working environment including the application of Jazz Pharmaceuticals Code of Business Conduct and Ethics.

• Experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience.
• 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 guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
• Has good project management skills and a proven ability to prioritise across multiple tasks.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Experience working with a globally distributed team.
• Good communication/interaction skills and ability to work in a dynamic and growing organisation.
• Experience of Risk Based Monitoring principles and using critical thinking to assess and manage risk on assigned studies.
• Possesses strong English language written and verbal communication skills.
• 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.
• Able to travel to off-site meetings or training seminars as needed.

• BA/BS, preferably in the scientific/healthcare field.