Senior Clinical Data Manager in London

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.

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:

• Lead a complex clinical study or a series of related studies with minimal guidance.
• 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.
• Represent Data Management on the study team for assigned studies.
• Manage and monitor the progress of data management activities and vendors on assigned studies.
• Collaborate with Medical Monitors, Clinical Pharmacologists, Statisticians, Phase I-unit teams, and CRO counterparts 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.
• 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.
• 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.
• 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.
• 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.
• Contribute to or lead department process improvement initiatives which could include the development of data management SOPs, Work Instructions, and process documents.

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.
• 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.
• 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.
• Experience supporting Phase I HV Clinical Pharmacology, or First-in-Human studies.

Required/Preferred Education and Licenses:

• BA/BS, preferably in the scientific/healthcare field.

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.