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Planet Pharma · 23 hours ago

eCOA Training Manager

San Francisco, CA

Full-time

Onsite

Senior Level, Lead/Staff

$80/hr - $100/hr

15+ years exp

Planet Pharma is a company focused on the Biotech and Pharmaceutical industry, and they are seeking an eCOA Training Manager to oversee the development and management of training materials related to electronic clinical outcome assessments. The role involves coordinating with vendors, developing training modules, and ensuring compliance with training standards for clinical studies.

BiotechnologyHealth CarePharmaceutical

Responsibilities

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

Qualification

ECOA training developmentVendor managementClinical outcome assessmentsBiotech industry experiencePharmaceutical industry experienceSlide presentation creationTraining curriculum maintenanceCommunication skills

Required

Bachelor's degree, advanced degree a plus

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