# Clinical Trial Manager I

**Company**: Syneos Health
**Experience**: entry
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/Clinical-Trial-Manager-I_25104738?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_6f12fb4b-4db

## Description

Syneos Health is seeking a Clinical Trial Manager I to join their team. The successful candidate will perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

Responsibilities:

- Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits

- Evaluate overall performance of site and site staff, providing recommendations regarding site-specific actions

- Verify process of obtaining informed consent has been adequately performed and documented for each subject/patient

- Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site

- Conduct Source Document Review of appropriate site source documents and medical records

- Verify required clinical data entered in the case report form (CRF) is accurate and complete

- Apply query resolution techniques remotely and on-site, and provide guidance to site staff as necessary

- Utilize available hardware and software to support the effective conduct of the clinical project data review and capture

- Verify site compliance with electronic data capture requirements

- Perform investigational product (IP) inventory, reconciliation, and reviews storage and security

- Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness

- Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents

- Support subject/patient recruitment, retention, and awareness strategies

- Enter data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution

- Understand project scope, budgets, and timelines, and manage site-level activities/communication to ensure project objectives, deliverables, and timelines are met

- May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA)

- Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings

- Provide guidance at the site and project level towards audit readiness standards and support 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

- Good computer skills and ability to adapt to new technologies

- Excellent communication, presentation, and interpersonal skills

- Ability to manage required travel of up to 75% on a regular basis

## 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/Clinical-Trial-Manager-I_25104738?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)