Description
We are seeking a Clinical Trial Manager I to join our team in Sao Paulo, Brazil. The successful candidate will have some experience in project management as a CTM or PM.
Job Responsibilities
- Performs site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
- Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site.
- Develops and implements site-specific actions and communicates/escalates serious issues to the project team.
- Maintains a working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
- May perform investigational product (IP) inventory, reconciliation, and reviews storage and security.
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness.
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents.
- Supports subject/patient recruitment, retention, and awareness strategies.
- Enters data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution.
- May act as primary liaison with project site personnel or in collaboration with another CRA or Central Monitoring Associate (CMA).
- Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
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.
- Excellent communication, presentation, and interpersonal skills.
- Ability to manage required travel of up to 75% on a regular basis.
What We Offer
Syneos Health offers a dynamic and supportive work environment, opportunities for career development and progression, and a range of benefits to support our employees.