Senior Clinical Data Manager
3 days ago
London
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 #J-18808-Ljbffr
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