Clinical Data Monitor

ROLE SUMMARY

  • The Clinical Data Monitor (CDM) is responsible for the clinical data review of one or more studies/programs, most often within a submission timeline.
  • The studies supported by the CDM are complex comparative safety and efficacy trials that are high-enrolling and require robust data capture.  In addition, the CDM ensures data readiness for important milestones including, but not limited to, interim analysis, final analysis, snapshots to support submissions, Data Monitoring Committee reviews and publications. 
  • Review tasks performed by the CDM include both point-to-point data checks and interpretive analysis.

ROLE RESPONSIBILITIES

  • The CDM will use data review best practices and associated data review tools to identify trends and any safety signals.
  • The CDM routinely provides functional management of studies and or compounds being reviewed.
  • The CDM will perform and coordinate the data review deliverables across studies and at the program level.
  • Follows relevant SOPs and regulations, has an excellent understanding of and complies with applicable training requirements, constantly seeking further improvements in quality and efficiency of clinical procedures.
  • Provides data review subject matter expertise support for studies, as needed, within Clinical Sciences group.

Qualifications

  • At least 7 years of clinical experience in pharmaceutical industry.
  • Extensive understanding of the processes associated with reviewing and delivering quality data.
  • Strong field monitoring experience an asset
  • Extensive Clinical Research experience, ideally on the side of the sponsor and with a track record of successful regulatory submissions
  • Strong background in Oncology
  • Strong technical data review skills and comfortable with the review of large sets of clinical data under often challenging timelines.
  • Familiar with database systems; technically competent with Microsoft Excel and ideally, Access.
  • Possesses at least basic knowledge of data management including case report form design, workings of electronic edit checks, implementation of data handling conventions and interpretation of data status reports.

QUALIFICATIONS

  • Bachelor’s degree in one of the disciplines related to life sciences, drug development or business.
  • Advanced degree is desirable.
  • At least 7 years of clinical experience in pharmaceutical industry.
  • Extensive understanding of the processes associated with reviewing and delivering quality data.
    • Some travel may be required

EEO & Employment Eligibility

TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.   TP Therapeutics is an E-Verify employer.

To apply, please submit your resume to hr@tptherapeutics.com