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.
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Senior Clinical Data Manager employer: Jazz Pharmaceuticals
Jazz Pharmaceuticals is an exceptional employer, offering a dynamic work culture that prioritises innovation and collaboration in the biopharma industry. With a strong commitment to employee growth, we provide numerous opportunities for professional development and a competitive benefits package, including flexible paid vacation and comprehensive health insurance. Located in vibrant cities like London and Cambridge, our employees enjoy a stimulating environment that fosters creativity and teamwork while making a meaningful impact on patients' lives worldwide.
