Sr Central Risk Manager UK - Sponsor Dedicated

Job Responsibilities
Provides advice and subject matter expertise for the development of the monitoring strategy required for the project and where required, advises the project team on any updates to the monitoring strategy during the study based on risks.

• Works with cross-functional leads to understand complex indications and risks and seeks input on risk mitigations.
• Provides guidance to cross-functional leads to ensure consistency within programs, therapeutic areas and/or sponsors.
• Drafts initial risk assessment, supports the project team in ensuring cross-functional involvement in the finalization of the RACT.
• Ensures PL transfers risks identified to the correct tracking system and supports ongoing crossfunctional review of risks throughout the project.
• Provides advice on the development of functional plans to ensure identified risks are mitigated.
• Assesses tools where available to conduct remote data review and centralized statistical monitoring, identifying risks to data quality and integrity.
• Facilitates review of findings with the internal cross- functional team and sponsor. Requires support from cross-functional leads on complex risks and mitigations.
• With support and where required, collaborates with other team members and Sponsor to identify Quality Tolerance Limits.
• As required, provides development and delivery of initial and ongoing training to the study team regarding the risk assessment, centralized monitoring and the wider risk-based monitoring strategy implementation.
• Collaborates with other functional areas to ensure risks identified in compliance and delivery according to protocol, ICH/GCP and/or Good Pharmacoepidemiology Practices (GPP) and country regulations, including medical monitoring, Safety, Quality Assurance (QA). Ensures Inspection Readiness for risk assessment and centralized monitoring scope.
• Understands the study scope of work, budget and protocol content for their assigned study. Escalates to the PM any risk assessment and centralized monitoring deliverables (timeline, quality, and budget) at risk, and any activities and requests which are out of contracted scope.
• May participate in business development activities including monitoring strategy and budget input, defines meetings and proposal development.

Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. 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.

Syneos Health is an equal opportunity employer.