Senior Clinical Data Manager

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 www.jazzpharmaceuticals.com for more information.

About The Role

Responsible and accountable for planning, organization, leadership and coordination of all data management activities on assigned Studies (Phase I to IV) from database set-up to project closure with minimum supervision. Oversees and works closely with assigned CRO Data Management Teams to ensure quality and timely data management deliverables.

Responsibilities

• Responsible for performing all tasks in adherence to GCP guidelines
• Coordinate and review the generation of data management documents including but not limited to the Case Report Form, Data Management Plan, Annotated CRF, Database Specifications, Data Validation Plan, Data Entry and Review Guidelines, CRF Completion Guidelines, SAE Reconciliation Procedure and Data Transfer Agreements for assigned studies
• Oversee all Study related data management activities for outsourced Studies including but not limited to eCRF design, database set-up, user acceptance testing (UAT), data collection, edit checks & offline listings review, external data reconciliation, medical coding, quality control of database, database locks and archival of data management documents
• Work closely with other GW functional groups/vendors and provides input to the set-up of other data collection systems (eCOA, RTSM etc). Ensures integrated variables between EDC and these systems are set-up, tested and approved prior to database go-live.
• Liaise with GW’s Pharmacovigilance team and Data Management vendor to ensure Serious Adverse Events reconciliation is completed at agreed intervals (where applicable).
• Liaise with external vendors and Data Management CRO teams to ensure Data Transfer Specifications are created/reviewed/approved and the transfer files are sent at agreed intervals.
• Ensure the in-house data review is scheduled and completed in a timely manner. Also, co-ordinate the data review by clinical, medical and stats teams.
• Review study metrics to determine risks and plans risk mitigation as required
• Participate in Study team meetings as primary Data Management representative, providing regular status updates and metrics to the cross functional team.
• Work with the Clinical Data Management, Senior Manager and Clinical Project Manager set-up and continuous monitoring of status reporting of the DM timelines for assigned studies
• Responsible for filing of DM specific documents in the study electronic Trial Master File on an ongoing basis and co-ordinates study archive

Requirements

Knowledge:

• Bachelor’s or Master’s Degree in Life Sciences
• Demonstrate sound knowledge of Drug Development Process and Clinical Data Management processes.
• Good Knowledge of ICH and GCP guidelines

Experience

• Strong experience in Clinical Data Management.
• Experience leading Studies from study start-up to database lock.
• Experience with study start up and closeout

Skills

• Excellent verbal and written communications skills and ability to interact with personnel at all levels cross functionally
• Ability to think critically and use good problem solving skills
• Strong organizational and time management skills
• Excellent attention to detail

Attributes And Behaviours

• Develops and maintains positive working relationships with others
• Shares ideas and information
• Assists colleagues as and when required
• Demonstrates a ‘can do’ approach

Desirable

• Knowledge of SAS and CDISC data standards e.g. CDASH, SDTM

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.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html.