Clinical Trial Manager

**Description**

**Clinical Trial Manager**

Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason - we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.

**Why Syneos Health**
- #SyneosHealthLife means we’re committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
- We believe our success is a direct result of the people who are driving it - you We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

**Summary**

The Site Excellence Partners are accountable for safeguarding the quality and patient safety at the investigator site and are responsible for site and monitoring oversight. The Site Excellence Partner is responsible for utilizing
and interpreting data from analytic tools, in conjunction with country and regional intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks. The Site Excellent Partners are accountable for identifying Monitor performance issues and are responsible for ensuring appropriate corrective and preventative actions are put in place.

**Responsible for process, standards, and oversight**:
Responsible for site and monitoring quality, regulatory and GCP compliance.
Drive inspection readiness and provide support for site audits/inspections as needed, following through
audit/inspection finding to resolution.
Follow the risk prediction tools and plans (e.g., IQMP, the Site Quality Risk Dashboard) and proactively put in
place mitigations for known/anticipated risks.
Responsible for site and monitoring quality using and interpreting signals identified by Signal Interpretation
Leads in conjunction with local country intelligence to proactively identify risks. Lead risk assessment at the
site/country level for their studies, including identifications of mitigation and control.
Maintain knowledge of appropriate tools and resources (e.g., metrics, site health, Central Monitoring signals,
Dashboards etc.). Demonstrate use of data to enhance quality and accelerate study delivery.
mitigation and control.
- Conduct and report oversight activities, both remote and onsite visits, according to Client requirements and
standards.
Perform additional oversight visits/reviews based on the type of issues that arise during the course of a
study, and the analytics and visualizations outputs. These may be conducted with the assigned Monitor or alone
depending on the nature of the issue(s).
Accountable for identifying site and Monitor performance issues and quality events and other quality issues
at patient and/or site level, escalating, and supporting implementation of CAPAs to address these.
Review of monitoring visit reports.
Support development and delivery of decentralized capabilities at investigator sites.

**Protocol Site Oversight**
Maintain a thorough knowledge and understanding of assigned protocols, including associated risks and
mitigations, as it relates to site and monitoring quality.
Attend Investigator meeting/protocol training to ensure clear understanding of the protocol requirements.
**Site and Study Management Interface**
Support local Investigator relationship management with the Site Relationship
Partner and Country Trials Manager if required.
Serve as point of contact for quality and safety escalations for CRO, Monitors, Site Relationship
Partner, Country Trials Manager and Study Team.
Support the resolution of operational obstacles at the site / country level in order to advance the
site and study deliverables.

LI-AG1

**Qualifications**

Qualifications - External

**What we’re looking for**
A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical
BS/BSc/MS/MSc or equivalent + 5 years of clinical research experience
English is essential. Proficiency in more than one language is preferred.
**Experience**
Solid knowledge of clinical development processes with strong emphasis on monitoring.
Demonstrated ability to oversee a 3rd party and/or dem