Clinical Data Analyst, Clinical Data Management

San Diego, CA

  • We are seeking a responsible, dynamic, creative and highly motivated Clinical Data Analyst to join our Clinical Data Management (CDM) team to help with the creation and maintenance of clinical databases.
  • This opportunity involves collaborating with others to effectively and efficiently perform data oversight activities.
  • This position is expected to proactively identify and undertake data-related problems and propose solutions.
  • This is a full-time position in the company’s San Diego headquarters. 

Specific Responsibilities

  • Performing all aspects of the data cleaning process, with a high degree of accuracy and in accordance with Good Clinical Practices and Standard Operating Procedures, that include but are not limited to data listing reviews and third-party vendor data reconciliation
  • Supporting the Project lead where necessary with database testing and development, vendor/data management, and internal document creation and maintenance
  • Working in tandem with the CDM team to develop a standardization of design, documentation, testing, and implementation of clinical data collection (i.e., CRF standards), and clinical database review
  • Providing input and review of Data Management Plans, eCRF Completion Guidelines, and Manual Review Listing Plans
  • Query management from functional group listing and data reviews followed by oversight of proper site update and/or response and appropriate application of internal query guidelines
  • Assisting with organizing data reviews and issue management from internal, cross-functional and central monitoring reviews

Requirements

  • College degree(s) in Life Sciences, Computer Science or Business preferred
  • 2-3 years of relevant clinical experience in a Pharmaceutical, Biotech or CRO environment preferred
  • GCP and regulatory knowledge including FDA and ICH regulations
  • A flexible attitude with respect to work assignments and continued industry related education
  • Efficiently organizes workload of several simultaneous studies to ensure critical milestones are met, while also maintaining an expectation of quality work
  • Must have ability to innovate, think strategically and conceptually, and manage multiple projects simultaneously
  • Ability to handle even difficult situations professionally and maintain a professional and caring demeanor
  • Proven ability to collaborate in a team environment and work independently
  • Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment

Please submit your resume or additional inquiries to apply@samumed.com