# Clinical Trial Manager I

**Company**: Syneos Health
**Location**: Sao Paulo
**Work arrangement**: hybrid
**Experience**: mid
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/BRA-Client/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-_25109711?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_6d4ab258-4bd

## 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.

## Skills

### Required
- Good Clinical Practice
- ICH Guidelines
- regulatory requirements
- computer skills
- communication skills
- interpersonal skills

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/BRA-Client/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-_25109711?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)