Site Excellence Partner

The Site Excellence Partner safeguards the quality and patient safety at the investigator site and are responsible for site and monitoring oversight.

They proactively identify risks to quality and compliance and develop and implement mitigation plans to address these risks. They identify CRA 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, protocol, regulatory and GCP compliance.

•Follow the risk prediction tools and plans and proactively put in place mitigations for known/anticipated risks.

•Drive inspection readiness.

•Conduct and report oversight activities, both remote and onsite visits, according to the requirements and standards.

•Maintain a thorough knowledge and understanding of assigned protocols, including associated risks and mitigations, as it relates to site and monitoring quality.

•Site and Study Management Interface

•Serve as point of contact for quality and safety escalations for CRO, CRAs, Site Relationship Partner, and Study Team.

•Responsible for site and monitoring quality.

•Apply knowledge of data and analytics to target site and study review, recommend and implement actions for mitigation and control.

•Provide support for site audits/inspections.

•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.

•Work with CRO Monitors, and other company and CRO colleagues as appropriate, to drive resolution of oversight issues.

•Support the resolution of operational obstacles at the site / country level in order to advance the site and study deliverables.

•Support local Investigator relationship management with the Site Relationship Partner if required.

•Following through audit/inspection finding to resolution.

•Support development and delivery of decentralized capabilities at investigative sites.What we're looking for
• 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.
• Knowledge of basic clinical project financial principles
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills
• Excellent communication, presentation and interpersonal skills.
• Ability to apply problem solving techniques to resolve complex issues, and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.
• Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues
• Moderate travel may be required, approximately 20%

Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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