Senior Clinical Data Manager

Jazz Pharmaceuticals; Greater London; Remote; GBP 70,000 - 100,000; Full time

Job summary

Jazz Pharmaceuticals is seeking a Senior Clinical Data Manager to lead data management activities for early-phase HV studies and multi-disciplinary programs. The role partners with Clinical Pharmacology, Medical Monitoring, Biostatistics, and Phase I units to ensure timely, inspection-ready data for safety reviews and dose escalation decisions.

The candidate will manage data management tasks across studies, oversee CROs, and contribute to study governance, with extensive experience in EDC/eCOA

Qualifications

• At least five years’ experience in Data Management for pharma/biotechnology, or equivalent in FDA-regulated environment.
• Minimum two years leading Phase I (HV) studies.
• Understanding regulatory guidelines and industry standards (ICH/FDA, CDISC, GCDMP, 21 CFR 11, MedDRA).
• Strong project management skills with ability to prioritize multiple tasks.
• Excellent written and verbal English; able to work with a global team.

Responsibilities

• Lead data management activities for early phase HV studies (SAD, MAD, bioavailability, etc.).
• Represent Data Management on the study team and manage CRO/vendors.
• Lead design/testing of EDC systems; resolve related issues with the team.
• Develop data management documents and data edit check specifications.
• Mentor junior Data Management staff and assist with onboarding.

Skills

Data Management

Phase I HV studies

Regulatory guidelines

Project management

Attention to detail

Communication

Education

BA/BS in scientific/healthcare field

Tools

EDC systems

eCOA

IRT

Job description

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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