eCOA Training Manager

eCOA Training Manager (TEMP) This position is responsible for the eCOA Training Management including (but not limited to) the following examples of functional tasks:

• eCOA training module development with the training vendors for the eCOAs
• Support the oversight of the development for the Rater Training program by eCOA/BDA vendor [including Rater qualification and training materials]
• Project delivery and oversight of all other training materials developed by vendors related to the clinical outcome assessments for the study team, CRAs, and Investigators/sites (e.g., CRA training content and re-training or Investigator Meetings).
• Develop and create other training materials to support the Development Operations team as requested to support the studies
• Review and coordinate the internal cross-functional review of all training materials developed by vendors, schedule adjudication meetings internally to address the comments/design, and maintain the training curriculum
• Monitoring of KPI metrics, site/rater compliance, patient diary compliance

Remote role, some travel required (will be expensed) needs to be available in PST but manager is flexible with location.

• 15+ years industry experience in Biotech or Pharmaceutical industry, training development or related discipline is required
• Experience in the development of training material and/or training curriculum for clinical outcome assessments is required, and indication experience in dermatology a plus
• 3-5 years of vendor management experience for service providers in electronic clinical outcome assessments (eCOA) (e.g., service providers such as Signant Health, Suvoda, Medidata, CRF Health, Clario, CLIN Ink)
• History of leadership roles and subject matter expertise for eCOAs including training module development strategies
• Develops training for procedural documents including instruction courses, quizzes, exams and other training materials
• Responsible to design and develop the content and format of training materials for effective learning. Also includes coordinating and maintaining the training curriculum with functional area input
• Strong written, verbal communication, and slide presentation creation.

Bachelors degree, advanced degree a plus