Senior Clinical Data Manager

If you are a current Jazz employee please apply via the Internal Career site.

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. Please visit www.jazzpharmaceuticals.com for more information.

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, with experience in Phase I Healthy Volunteer (HV) 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.

For Phase I HV studies, the Senior Clinical Data Manager will partner closely with Clinical Pharmacology, Medical Monitoring, Biostatistics, Bioanalytical, and Phase I Unit personnel to ensure timely, accurate, and inspection-ready data are available to support safety reviews, dose escalation decisions, and study conduct.

Essential Functions/Responsibilities

• Be able to lead a complex clinical study or a series of related studies with minimal guidance.
• Be able to lead data management activities for early phase HV clinical pharmacology studies including Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), food effect, drug-drug interaction, bioavailability, bioequivalence, and first-in-human studies.
• 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.
• Collaborate with Medical Monitors, Clinical Pharmacologists, Statisticians, Phase I-unit teams, and CRO counterpart to support real-time review of emerging safety, PK, PD, ECG, laboratory, and biomarker data.
• Review protocols for appropriate data capture requirements including electronic Case Report Form (eCRF) design and electronic Clinical Outcome Assessments (eCOA) forms.
• Review protocols and schedules of assessments to ensure appropriate data collection for intensive sampling, confinement periods, dosing events, and other activities unique to HV studies.
• 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

• 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, with a minimum of two years leading Phase I (HV) studies.
• 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.

Essential Functions/Responsibilities

• Be able to lead a complex clinical study or a series of related studies with minimal guidance.
• Be able to le
• ad data management activities for early phase HV clinical pharmacology studies including Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), food effect, drug-drug interaction, bioavailability, bioequivalence, and first-in-human studies.
• 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.
• Collaborate with Medical Monitors, Clinical Pharmacologists, Statisticians, Phase I-unit teams, and CRO counterpart to support real-time review of emerging safety, PK, PD, ECG, laboratory, and biomarker data.
• Review protocols for appropriate data capture requirements including electronic Case Report Form (eCRF) design and electronic Clinical Outcome Assessments (eCOA) forms.
• Review protocols and schedules of assessments to ensure appropriate data collection for intensive sampling, confinement periods, dosing events, and other activities unique to HV studies.
• 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

• 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, with a minimum of two years leading Phase I (HV) studies.
• 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.
• Experience in supporting Phase I HV Clinical Pharmacology, or First-in-Human studies.
• Knowledge of reconciliation and quality review processes for bioanalytical, central laboratory, ECG, and other external vendor data.
• Experience supporting interim analyses, cohort reviews, and dose escalation decision-making processes.
• Demonstrated experience supporting rapid database development, real-time data cleaning, and accelerated study execution timelines.
• Strong understanding of pharmacokinetic (PK), pharmacodynamic (PD), ECG, laboratory, biomarker, and other clinical pharmacology data.
• Experience supporting interim analyses, cohort reviews, and dose escalation decision-making processes.
• Experience working in fast-paced early development environments where timely availability of high-quality data is critical to study progression.
• 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-DM1

#LI-Remote

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.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html.