Senior Clinical Data Manager (Contractor)

Biometrics South San Francisco, California


Description

C:\Users\brusch\AppData\Roaming\Zoom\data\9y8of7vgsn2iumkzpaxzuq@xmpp.zoom.us\vsth3v7xtoesej5n44ycfa@xmpp.zoom.us\{AC518B2E-4324-48CD-BE40-8C37C000F64D}.png
Senior Clinical Data Manager (Contractor)

 

Requisition ID: 325

 

Position Summary

The Temporary Sr. Clinical Data Manager will support the Data Management group from study start-up through database lock and clinical study report. The successful candidate will deliver high quality data, on time and on budget. In this role, the candidate will be expected to lead and provide oversight for the execution of data management activities for more than one compound in a therapeutic area. This role will report to the Associate Director, Clinical Data Management.

 

Responsibilities

  • Works collaboratively with Clinical Programmers, Statistical Programmers, Biostatisticians, Clinical Research, DSPH, Regulatory and Project Management staff to meet project deliverables and timelines for moderately complex clinical data acquisition, quality checking and reporting
  • Ensures completeness, correctness and consistency of clinical data and data structure across all projects
  • Communicates with all departments regarding project statuses/issues; provides ongoing feedback on data management workflows to increase efficiency and provide feedback to CRAs
  • Partners with clinical study team to create the clinical data management plan (CDMP), including CRF development, data validation specifications, data transfer specifications, and clinical listings and reports
  • Oversees interactions with outside vendors (e.g. clinical laboratories) on collection, transmittal, reconciliation and transfer of study specific data
  • Performs CDM Systems activities and provides ongoing oversight (EDC Study Build, UAT/study database validation, edit check specification)
  • Vendor management and oversight of all CRO data management activities to ensure proper execution of data management plans, including communicating data trends/observations and relevant metrics with study team members, participating in regular team meetings and assisting in the creation of study timelines
  • Ensures guidelines and specifications on validation procedures and data transfer procedures are followed
  • Maintains appropriate documentation surrounding maintenance and archival of clinical data
  • Manages multiple and varied tasks; prioritizes workload with attention to detail
  • Participates in the development, review and implementation of processes, policies, SOPs and associated documents affecting CDM
  • Performs other duties as assigned 

 

Qualifications

  • Works collaboratively with Clinical Programmers, Statistical Programmers, Biostatisticians, Clinical Research, DSPH, Regulatory and Project Management staff to meet project deliverables and timelines for moderately complex clinical data acquisition, quality checking and reporting
  • Ensures completeness, correctness and consistency of clinical data and data structure across all projects
  • Communicates with all departments regarding project statuses/issues; provides ongoing feedback on data management workflows to increase efficiency and provide feedback to CRAs
  • Partners with clinical study team to create the clinical data management plan (CDMP), including CRF development, data validation specifications, data transfer specifications, and clinical listings and reports
  • Oversees interactions with outside vendors (e.g. clinical laboratories) on collection, transmittal, reconciliation and transfer of study specific data
  • Performs CDM Systems activities and provides ongoing oversight (EDC Study Build, UAT/study database validation, edit check specification)
  • Vendor management and oversight of all CRO data management activities to ensure proper execution of data management plans, including communicating data trends/observations and relevant metrics with study team members, participating in regular team meetings and assisting in the creation of study timelines
  • Ensures guidelines and specifications on validation procedures and data transfer procedures are followed
  • Maintains appropriate documentation surrounding maintenance and archival of clinical data
  • Manages multiple and varied tasks; prioritizes workload with attention to detail
  • Participates in the development, review and implementation of processes, policies, SOPs and associated documents affecting CDM

 

Portola Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any characteristic protected by law.