Senior Clinical Data Manager

Senior Clinical Data Manager

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.

Essential Functions/Responsibilities:

• Represents Data Management on the study team for assigned studies.
• Manages and monitors the progress of data management activities and vendors on assigned studies.
• Manages and monitors CRO progress for outsourced studies.
• Builds effective relationships with CRO/vendor counterparts.
• Reviews protocols for appropriate data capture requirements including electronic Case Report Form (eCRF) design and electronic Clinical Outcome Assessments (eCOA) forms.
• Interacts with study team members e.g., CRAs, programmers, CTMs and statisticians in designing eCRFs and CRF completion guidelines.
• Leads the design and testing of Electronic Data Capture (EDC) systems according to company standards.
• Able to resolve EDC system issues with team members.
• Supports the development of other system set-up e.g., eCOA and Interactive Response Technology (IRT).
• Leads the development of data edit check specifications and data listings and runs data listings as required.
• Develops or leads 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.
• Provides 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.
• Leads database upgrades/migrations including performing User Acceptance Testing.
• Enters data queries into the EDC system to be resolved at investigational sites and manages the resolution of those queries.
• Performs reconciliation of data from external data sources against the clinical database.
• Performs Serious Adverse Event reconciliation activities.
• Performs database freeze and lock activities.
• Able to maintain study eTMF.
• Participates in the generation of study timelines and manages DM activities against the timelines.
• Provides mentoring and training to junior level Data Management staff assigned to his/her studies.
• Assists with the onboarding and/or training of new employees and/or contractors.
• Participates in regular Clinical Data Operations team meetings and provides input when appropriate.
• Contributes to or leads department process improvement initiatives which could include the development of data management SOPs, Work Instructions, and process documents.
• Contributes 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.