Central Monitor (UK/EUROPE)
Multiple Locations: United Kingdom • Serbia • Poland • France • Germany • Italy • Spain • Croatia • Romania • Portugal
Requisition Number: 3090
Position Title: Central Monitor
SUMMARY: Will conduct central monitoring activities for assigned clinical trials in accordance with ICH GCP E6 requirements.
- Serves as the Central Monitor within the assigned project team:
- Understands the assigned protocol and ensures central monitoring activities are planned and executed in alignment with it and in adherence to ICH-GCP, SOPs, corporate standards and regulatory requirements.
- Perform central monitoring activities including review of system outputs, identification of outliers, trends or signals and propose actions for assessment by study team. Follow-up with study teams as appropriate for action or issue resolution.
- Understands the study budget for their assigned tasks.
- Can provide subject matter expertise for the delivery of the centralized monitoring strategy required for the trial.
- As required, develops and delivers training to the study team regarding the centralized monitoring strategy.
- Ensures the documentation of the centralized monitoring strategy in the appropriate functional plan and/or development of the central monitoring plan.
- Depending on experience, may contribute, along with other functional representatives, to the identification of critical data and processes and the development of the Risk Planning Tool.
- Depending on experience, may contribute to the cross-functional review of risks throughout the trial.
- Ensures Inspection Readiness for centralized monitoring scope.
- Conducts and documents study/site level review of Key Risk Indications/Key Performance Indicators and where required, statistical monitoring and tracking of study Quality Tolerance Limits
- To participate as required in sponsor meetings and audits or other third-party meetings.
OTHER SKILLS AND ABILITIES:
- Excellent communication, presentation and interpersonal skills.
- Excellent planning and organizational skills with effective time management
- Excellent interpersonal skills
- Knowledge of clinical project financial principles
- Ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identify and mitigate potential threats to the successful conduct of a clinical research project.
- Critical thinking and analytical skills to understand/ analyze complex data and provide insight into risk reports, trends and outliers in data
- Computer literate and numerate with a willingness to adapt to various computer systems.
- BSc/RN or equivalent combination of knowledge, skills and experience
- At least 4 years’ experience in clinical research required
- Prior experience of Central Monitoring and associated ICH/Regulatory guidance required
- Demonstrates critical thinking skills to determine the cause and appropriate solution in the identification of issues.
- Demonstrated capability of working in global environment
Employment Type: Regular
Community / Marketing Title: Central Monitor (UK/EUROPE)
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Belgrade, Vojvodina RS