Senior Clinical Data Manager

  • OMI,
  • San Carlos, CA
  • 3 weeks ago
Lead a clinical study with minimal guidance, Experience with RAVE database builds, 7 years in Clinical Data Management
Contract W2, 6 Months
$54 - $55

Job Description

The Contract Senior Clinical Data Manager will be responsible for performing end to end Data Management activities. He/she will participate as an active member of a multi-disciplinary team to plan, lead and execute the Data Management tasks required for phase 1-4 studies. The Senior Clinical Data Manager must have a broad, fundamental knowledge of the data management process and should be able to perform most required tasks with minimal guidance.

The Senior Clinical Data Manager should be able to:

  • Lead a large clinical study or a series of related studies with minimal guidance
  • Build a study database in RAVE
    • Represent Data Management at study management team meetings
    • Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
    • Be able to perform a thoroughly detailed review of eCRF data requirements and create one if need be
    • Interact with CRAs, programmers, study operations lead and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
    • Lead the development of data edit check specifications and data listings
    • Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company processes
    • Able to resolve EDC system issues with team members
    • Review  migration reports and ALS to ensure database build accuracy
  • Develop or lead the development of the Data Management Plan for a clinical study.
  • Able to review and provide feedback to the clinical team on other study documents Statistical analysis plans and vendor specifications
  • May provide training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed
  • Perform reconciliation of data from external data sources against the clinical database
  • Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
  • Lead database upgrades/migrations including performing User Acceptance Testing
  • Perform database lock and freeze activities per company SOPs

 

Essential requirements:

 

  • At a minimum, Bachelor's Degree required in the scientific/healthcare field.
  • At least 7 years' experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience
  • RAVE database build experience is a must
  • Must have good project management skills and a proven ability to multitask
  • Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
  • Possesses strong English language written and verbal communication skills.
  • Experience in working with oncology studies is a must
  • Able to travel to off-site meetings or training seminars as needed.
  • Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications.
  • Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is a must
Dice Id : 10410997
Position Id : 6883214
Originally Posted : 1 year ago
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