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Sr. Clinical Data Specialist
Ref No.: 15-04085
Location: Pleasanton, California
Provide very senior level technical and functional expertise as part of the Clinical Project Teams; serve as the primary Data Management representative.
Drive the development of the Case Report Forms following the dictates of the protocols, following CDASH/CDISC standards and complying with RMS data collection standards.
Serve as the subject matter expert on data collection strategy, EDC system functionality and receipt and handling of electronic study data.
Serve as Lead Data Manager, managing the day-to-day activities on multiple projects from study start up through database lock.This may include the management of external service providers, e.g., Contract Research Organizations.
Daily responsibilities include, but are not limited to, the development of study documentation, development of database specifications, Data Transfer Agreements and other study documents.Participation in database validation and UAT, managing the ongoing review of study data, query issuance and resolution, reporting study metrics, handling of electronic transfers, data auditing and database locking.
Serve as a strong technical liaison between Data Management and SAS Programming specific to the electronic transfer process activities.
Extensive experience managing varying data sources, e.g., eCRF data as well as external data, e.g., lab data and/or test results from diagnostic instruments.
Comprehensive knowledge of electronic data handling, storage and archiving best practices.
Ability to manage large volumes of incoming electronic transfers daily.
Serve as Data Management project manager for large projects and/or multiple projects.
Acts as consultant for project teams and managers in the area of Data Management processes and process improvement.
Manages vendor contracts, invoice review/approval and accrual reporting, as needed.
Mentors other members and DM Leads in training and developing data management expertise.May directly supervisor lower level team members.
Independently brings project solutions to the DM teams and management.
Incumbants may be required to perform other duties as required.
  • B.S. degree in biological sciences, computer science, or related field, or equivalent combination of education and work related experience.
  • 6-8 years of experience working with relational databases
  • 6-8 years of pharmaceutical, biotech, medical device and/or diagnostic industry experience
  • Knowledge of GCP, CDASH/CDISC and FDA requirements regarding clinical data management documentation and software.
  • Thorough knowledge of 21 CFR Part 11 compliance
  • Project & Time Management
  • MS Excel
  • MS Office/Powerpoint/Project office
  • Familiarity with EDC applications (e.g. Medrio, Inform, RAVE)
  • < >Use of commercial data query tools (e.g., Office Analytics)
SAS Programming (desired, not required)