[Hiring] Senior Clinical Data Manager @Jazz Pharmaceuticals

Role Description

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:
  • Case Report Form
  • Data Management Plan
  • Annotated CRF
  • Database Specifications
  • Data Validation Plan
  • Data Entry and Review Guidelines
  • CRF Completion Guidelines
  • SAE Reconciliation Procedure
  • 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 provide input to the set-up of other data collection systems (eCOA, RTSM etc). Ensure 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 to set-up and continuously monitor the 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-ordinate study archive.

Qualifications

• 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.

Requirements

• 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.

Benefits

• Eligible to participate in various benefits offerings, including, but not limited to:
  • Medical, dental and vision insurance
  • Retirement savings plan
  • Flexible paid vacation