About the role

  • Ensure the quality and integrity of data collected in clinical studies and the privacy of patient data
  • Ensure efficient recording and reporting of safety-related issues
  • Conduct all clinical data management functions (lead clinical study set-up, migrations, conduct/maintenance to database lock)
  • Create complex metrics to identify trends in data and remediation and utilize tools/reports to assess training needs
  • Define and specify clinically complex data collection requirements (eCRFs, CRFs, edit checks, collection of external data)
  • Define, perform, and coordinate user acceptance testing (test scripts and checklists)
  • Lead project management activities for multiple multi-site and multi-cohort projects, including team meetings, timelines, and stakeholder communications
  • Develop and maintain Data Management deliverables including data management plans (DMPs), training materials and user aids
  • Evaluate data errors and collection issues and provide guidance and recommendations for resolution
  • Perform Site/User Administration for database access and ensure users are qualified
  • Lead development and review of SOPs, work instructions, and associated CDM documents and participate in user training
  • Perform other incidental duties assigned by Leadership

Requirements

  • Bachelor's degree and 5 years of previous related experience in clinical research including clinical data management and/or clinical data entry OR Associate degree or equivalent in a related field and 7 years of previous related experience in clinical research including clinical data management and/or clinical data entry
  • Experience with Medidata Rave EDC (Electronic Data Capture)
  • Minimum of 2 years leading clinical studies combined with 5 years of relevant experience in clinical research (preferred)
  • Full knowledge of protocols, DMPs, SAPs, Database Specification, and Data Validation Specification (preferred)
  • Proven expertise in Microsoft Office Suite (preferred)
  • Advanced Excel skills (pivot tables and formulas) (preferred)
  • Microsoft Power BI (preferred)
  • Project management skills and ability to lead cross-functional meetings (preferred)
  • Full knowledge of processes and procedures in clinical data management (preferred)
  • Excellent written and verbal communication and interpersonal relationship skills, including negotiating and relationship management skills (preferred)
  • Excellent problem-solving and critical thinking skills (preferred)
  • Ability to work in a team environment and interact with senior internal and external personnel (preferred)
  • Must reside within a reasonable distance from the Irvine Corporate location and have ability to commute on required onsite days

Benefits

  • Competitive salaries
  • Performance-based incentives
  • Wide variety of benefits programs to address diverse individual needs of employees and their families

Job title

Senior Clinical Data Manager

Job type

Experience level

Senior

Salary

$106,000 - $135,000 per year

Degree requirement

Associate's Degree

Location requirements

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