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Clinical Risk Manager

Employer
Syneos Health
Location
Europe
Salary
Competitive
Start date
16 Oct 2019
Closing date
29 Oct 2019

Job Details

Syneos Health are currently recruiting for an experienced Clinical Risk Manager to join our Risk Based Monitoring team who can be based in office based or home based throughout Europe. We are looking for a dynamic individual who can hit the ground running and join this exciting department.

The position serves as the subject matter expert for Risk Management and Centralized Monitoring within the project team, accountable for ensuring the cross functional team complete all risk assessment activities. This role also has accountability for conducting centralized statistical monitoring and ensuring escalation of issues identified via RADaR are dealt with appropriately by the study team. The person may provide administrative line management, which includes oversight of training, compliance, performance, development and career management of direct reports.

Core 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. Will also provide guidance 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 initial risk assessment. Ensures PL transfers risks identified to the correct tracking system and supports ongoing cross-functional review of risks throughout the project. May provide advice on the development of functional plans. 

• Utilizes tools, where available, to conduct centralized statistical monitoring, identifying risks to data quality and integrity. Leads review of findings with the internal cross functional team and sponsor. 

• Where required, collaborates with other team members and Sponsor to identify and track Quality Tolerance Limits. Facilitating discussions on any resultant changes required. 

• Participates in business development activities including monitoring strategy and budget input, defense meetings and proposal development. 
• As required, provides development and delivery of initial and ongoing training to the study team regarding the risk assessment, centralized monitoring and the wider monitoring strategy,. 

• May evaluate staff’s competency to lead risk assessment activities and perform centralized statistical monitoring. 

• Coaches and mentors CRMs regarding functional delivery, evaluation of project risks, and action implementation. Also sets priorities for the CRM team to complete and manage. 

• 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. 

• Reviews the study scope of work, budget and protocol content and ensures CRM team members aware of the parameters. 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. 

 

 To succeed in this role you will need the following skills/experience:

• Significant experience in a Clinical leadership position

• Thorough understanding of GCP-R2 and Risk based monitoring

• Experience with Quality Risk Management Planning within a trial

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

• Prior line management experience preferred 

• Demonstrated ability to lead and align teams in the achievement of project milestones, as well as demonstrated capability of working in a global environment 

• Knowledge of clinical project financial principles 

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

• Must demonstrate good computer skills and be able to embrace new technologies 

• 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%

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

• Prior experience in clinical risk management required. 

• Prior line management experience preferred 

• Demonstrated ability to lead and align teams in the achievement of project milestones, as well as demonstrated capability of working in a global environment 

• Knowledge of clinical project financial principles 

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

• Must demonstrate good computer skills and be able to embrace new technologies 

• 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%

What happens next: 
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.

Disclaimer: 
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. 

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