Clinical Trial Manager - Future Roles - (mex)

Syneos Health

Mexico City, Mexico
On-site
Ich-gcp and/or good pharmacoepidemiological practices (gpp) compliance
Site qualification, initiation, monitoring, and close-out visits
Protecting subject confidentiality and data integrity
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.
  • Supports subject/patient recruitment, retention and awareness strategies and manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.

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 and/or Good Pharmacoepidemiological Practices (GPP) compliance
  • site qualification, initiation, monitoring, and close-out visits
  • protecting subject confidentiality and data integrity
  • Investigational Product (IP) management and reconciliation
  • Investigator Site File (ISF) and Trial Master File (TMF) reconciliation

Nice-to-have

  • adapt to changing priorities
  • support subject recruitment and retention strategies
  • audit readiness standards and support

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