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Syneoshealth3 days ago

Clinical Trial Manager I with some experience in project management as a CTM or PM - Sao Paulo, Brazil Client Based (50% of the time in client's office)

On-site · Sao Paulo, São Paulo, Federative Republic of Brazil

Type
Full Time
Level
Mid Level
Education
Bachelors Degree
Company size
Enterprise

Job Summary

Clinical Trial Manager I with experience in project management as a CTM/PM based in Sao Paulo, Brazil, with 50% time in the client's office. Responsibilities include site qualification, site initiation, interim monitoring, and site management activities to ensure regulatory, ICH-GCP, and GPP compliance; assess site performance and provide action plans; maintain knowledge of applicable guidelines and SOPs; verify informed consent processes; oversee data like CRFs and ISF/TMF alignment; perform source data review and query resolution remotely and on-site; manage IP inventory and labeling per protocol; ensure audit readiness and collaboration with Sponsor and site personnel; support subject recruitment and retention; coordinate with cross-functional teams and attend investigator/sponsor meetings. Qualifications include a Bachelor’s degree or RN in a related field, and knowledge of GCP/ICH guidelines and regulatory requirements; strong communication and interpersonal skills; willingness to travel up to high levels as needed.

Required Qualifications

  • Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements

Desired Qualifications

  • Clinical Trial Manager I with experience in project management as CTM or PM
  • site qualification
  • site initiation
  • interim monitoring
  • site management
  • ICH-GCP
  • GPP
  • regulatory compliance
  • informed consent
  • data integrity
  • Source Document Review
  • CRF
  • EDC
  • query resolution
  • investigator site file
  • ISF
  • TMF
  • audit readiness
  • investigator meetings
  • sponsor meetings
  • communication skills
  • travel flexibility
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Syneoshealth

Clinical Trial Manager I with some experience in project management as a CTM or PM - Sao Paulo, Brazil Client Based (50% of the time in client's office)

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