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
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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