Senior Clinical Data Manager

Location: Greater London

## Senior Clinical Data Manager Apply:
Remote:
UK - Home-Based:
Philadelphia, Pennsylvania:
London, United Kingdom:
Full time:
Posted 2 Days Ago:
R040234
** 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  for more information.

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…