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 or its satellite Dallas office.

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. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.