Senior Clinical Data Manager

Brief Description:

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. ​​Be able to lead acomplexclinical study or a series of related studies with minimal guidance. 

Essential Functions/Responsibilities

• ​RepresentsData Management on thestudy teamfor assigned studies.

• ​Manage and monitor the progressofdata management activities and vendors on assigned studies.Manage and monitor CROprogress foroutsourced studies.Build effective relationships with CRO / vendor counterparts.

• ​Review protocols forappropriate datacapturerequirementsincluding electronic Case Report Form (eCRF) designand electronic Clinical Outcome Assessments (eCOA) forms.

• ​Interact with study teammemberse.g., CRAs, programmers, CTMs and statisticians in designing eCRFsand 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 thedevelopmentof other system set-upe.g.,eCOAand InteractiveResponse Technology (IRT).

• ​Lead the development of dataeditcheck specifications and data listings and run data listings asrequired.

• ​Develop or lead the development of the Data Managementdocumentsfor a clinical study.

• ​Able to review and provide feedback to the clinical team on other study documents e.g., Clinical Monitoring plans, Statistical analysisplansand vendor specifications.

• ​Provide training on the EDCand/oreCOAsystem and/or eCRF Completion Guidelines at Investigator Meetingsand tointernal 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 tomaintainstudy eTMF.

• ​Participate in the generation of study timelines and manage DM activities against the timelines.

• ​Provide mentoring and training tojuniorlevel Data Management staff assigned to his/her studies.

• ​Assistwith the onboarding and/or training of new employees and/or contractors.

• ​Participate in regularClinical Data Operationsteam meetings and provide input whenappropriate.

• ​Contribute to or lead department process improvement initiatives which could includethe 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

Essential Functions/Responsibilities

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

• 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.

• 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

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

#LI-SM1

#LI-remote