Toronto, Ontario – Manager Clinical Data Management

Reports to: Vice President Clinical Pharmacology

Position Summary:

The Manager Clinical Data Management will manage the activities within the data management group and work with other groups at BPSI. They will use the necessary expertise to advance the capabilities of the DM team at BPSI in relation to database design and implementation, and to contribute to the effectiveness of DM services including CDISC standards.

Duties and Responsibilities:

  • Manage and mentor the members of the Data Management Team to ensure projects are being successfully executed on-time and within budget, and all aspects of project administration
  • Work collaboratively with other Pharmacokinetics staff, Biostatisticians, cross-departmentally within BPSI to meet project deliverables and timelines for clinical statistical programming and reporting
  • Lead the development of Data Management SOPs and train other staff. Review SOP from other departments as they related to DM.
  • Develop study specific database for mainly Phase I and BA/BE studies and potentially for Phase II-IV clinical studies
  • Lead the clinical data management process for clinical studies and data coordination are conducted effectively
  • Design and review CRF according to the study protocol
  • Create data management plans for projects and manage the execution of all plans
  • Develop and review electronic data edit checks for web-based forms
  • Involved in designing, developing & validating CDISC; SDTM and ADaM and Define-XML
  • Work with data specifications and format, PivotTable tool, data management, functions, and filters
  • Create, review, and process Data Clarification Forms and updates the databases,
  • Query data inconsistencies and revise case report forms in compliance with SOPs, client guidelines and regulatory agency guidelines
  • Manage and assist with data base audits as needed
  • Develop a testing/validation plan for utilizing existing resources and personnel to complete all validation testing within CDM team
  • Research and evaluate software for future data management needs
  • Coordinate with hosting vender
  • Review study specific materials created by other members of the DM group
  • Perform other miscellaneous activities as required

Qualifications:

  • BA or BS with a science or related background; equivalent experience in data management and a medical-related field may be substituted
  • A minimum of 5 years clinical data management related experience in both a pharmaceutical/biotech/device company
  • The proven ability to supervise others and think strategically to achieve business goals
  • Experience in developing CRF and setting up database
  • Awareness of applicable regulatory rules and guidelines: e.g. ICH, GCP, GDP etc.
  • Direct experience with FDA regulations for healthcare such as 21 CFR Part 11A a plus
  • Experience with Electronic Data Capture (EDC), study startup, and study closeout
  • Good understanding of CDISC SDTM/CDASH standards
  • Strong technical skills in database programming
  • The ability to multi-task and prioritize are essential
  • Must be proficient in Word, Excel, PowerPoint and Internet Explorer
  • Must have strong communication (both verbal and written), managerial, interpersonal, and client services skills, be highly organized and self-motivated

Please send your resume to resumes@biopharmaservices.com