Senior Clinical Data Manager

Brief Description

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. Be able to lead a complex clinical study or a series of related studies with minimal guidance.

Essential Functions/Responsibilities

• Represents 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.
• 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.

Required Knowledge, Skills, and Abilities

• 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 prioritize 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 organization.
• 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.

Required/Preferred Education and Licenses

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