# Clinical Trial Manager II

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

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/CAN-Remote/Clinical-Trial-Manager-II_25106328?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_6b4a966d-9cc

## Description

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.

The Clinical Trial Manager II role 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

- Identifies critical data and processes, protocol execution risks, and risk mitigations

- Reviews study scope of work, budget, and protocol content

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

- 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 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

- Coordinates training to the study team

- Oversees resourcing allocations for CRAs and Central Monitors

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

- Reviews project oversight dashboards and other clinical trial systems

- 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

- Demonstrates understanding of other functions' roles in achieving compliance and delivery

- Oversees CRAs and Central Monitors assigned to the study

- Provides feedback to line managers on staff performance

Qualifications:

- 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

- 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%

## Skills

### Required
- clinical trial management
- site management
- monitoring
- GCP
- regulatory compliance
- data integrity
- risk management
- problem-solving
- communication
- interpersonal skills

### Nice to have
- risk-based monitoring

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/CAN-Remote/Clinical-Trial-Manager-II_25106328?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)