# Clinical Trial Manager II - Sponsor Dedicated - Chile Home Based

**Company**: Syneos Health
**Location**: CHL-Remote
**Work arrangement**: remote
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/CHL-Remote/Clinical-Trial-Manager-II---Sponsor-Dedicated---Chile-Home-Based_25114574?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/clinical-trial-manager-ii-sponsor-dedicated-chile-3c4b12aa-72a/

## Description

Syneos Health is seeking a Clinical Trial Manager II - Sponsor Dedicated to work remotely from Chile.

The Clinical Trial Manager II - Sponsor Dedicated is responsible for site management oversight, clinical monitoring, and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance, and data integrity.

Key responsibilities:

- Oversees site interactions post-activation through site closeout, including patient recruitment, investigator payments, and other related activities

- Identifies critical data and processes, protocol execution risks, and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT)

- Reviews study scope of work, budget, and protocol content to ensure clinical project team awareness of contractual obligations and parameters

- Uses prior clinical experience, operational data, metrics, and reports to identify risks to clinical trial management deliverables

- Escalates risks to clinical trial management deliverables to the project manager

- Employs strategic thinking and problem-solving skills to propose and implement risk mitigations

- Participates in key meetings, such as Kick Off Meetings, and serves as an escalation point for communications with investigator site staff

- Collaborates with other functional leaders to coordinate delivery handoffs and meet expected study milestones

- Develops and maintains clinical study tools and templates, including the Clinical Monitoring Plan

- Coordinates training to the study team regarding protocol specificities, Case Report Form (CRF) completion, and Sponsor Standard Operating Procedures (SOPs)

- Oversees resourcing allocations for CRAs and Central Monitors, site assignments, and study team members' conduct

- Ensures quality of clinical monitoring, central monitoring, and site management deliverables

- Reviews project oversight dashboards and other clinical trial systems to oversee site and patient activities, study team conduct, and data updates

- Understands the monitoring strategy required for the study and participates in the development of the study risk assessment plan

- Reviews content and quality of site and central monitoring documentation

- Interacts with clients and other functional departments related to clinical monitoring, central monitoring, and site management activities and deliverables

- Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP, and country regulations

- Oversees CRAs and Central Monitors assigned to the study and assesses study-specific process and training compliance

- Provides feedback to line managers on staff performance

Requirements:

- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience

- Demonstrated ability to lead and align teams in the achievement of project milestones

- Demonstrated capability of working in an international environment

- Demonstrated expertise in site management and monitoring (clinical or central)

- Preferred experience with risk-based monitoring

- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements

- Good computer skills

- Good communication, presentation, and interpersonal skills

- Strong conflict resolution skills

- Demonstrated ability to apply problem-solving techniques to resolve complex issues

- Critical thinking to determine the cause and appropriate solution in the identification of issues

- Moderate travel may be required, approximately 20%

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## Skills

### Required
- Good Clinical Practice
- ICH Guidelines
- clinical trial management
- site management
- monitoring
- risk-based monitoring
- budget management
- conflict resolution
- problem-solving

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/CHL-Remote/Clinical-Trial-Manager-II---Sponsor-Dedicated---Chile-Home-Based_25114574?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)