Ctm - Future Roles (us)

Syneos Health

Morrisville, North Carolina, United States
On-site
Ich-gcp compliance
Protocol compliance
Site qualification and initiation
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance

Job Summary

  • Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance.
  • Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
  • Syneos Health is passionate about developing its people through career development, training, and a supportive culture, rewarding employees with valuable benefits and a quality-of-life balance.

Matching Summary

Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance.

Skills & Requirements

Must-have

  • ICH-GCP compliance
  • Protocol compliance
  • Site qualification and initiation
  • Site monitoring and close-out
  • Informed consent verification
  • Subject safety assessment
  • Clinical data integrity

Nice-to-have

  • Career development and progression
  • Total Self culture
  • Diversity of thoughts and backgrounds
  • Audit readiness standards

Key Requirements

  • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
  • Knowledge of Good Clinical Practice/ICH Guidelines
  • Ability to manage required travel of up to 75%

Work Rights

Not specified

Tailored Resume

Cover Letter