Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.
We are currently recruiting for an experienced Lead CMA to join our Risk Based Monitoring team who can be based in Farnborough, Edinburgh, Warsaw, Munich or Prague with some home working options. We are looking for a dynamic individual who can hit the ground running and join this exciting department
A brief summary of duties you will be involved in:
• Lead the project team in the initial and periodic risk assessments using a risk assessment tool and coordinate the risk assessment documentation.
• Create and maintain the quality risk management plan (QRMP) in collaboration with the project team
• Provide input into development of functional plans to ensure alignment with the QRMP
• Ensure timely and comprehensive review of information across all trial sources to identify issues including outliers, trends, inconsistencies, or other patterns as defined by the QRMP
• Present risk management status (e.g. identified risks, mitigation strategies, trends, etc.) at project team meetings and communicate issues
• Line manage team members
• Perform business development activities if required
• Data Handling, Reporting, Tracking and administrative tasks
• Performing management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines
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
• Education - BS/BA or equivalent with solid clinical trial monitoring experience
• Experience in Line managing preferred but no essential
• Experience in performing business development activities
• Previous nominal practical experience in conducting clinical pharmaceutical research studies in a hospital setting, pharmaceutical company or CRO in the area of Medical Devices.
• Good understanding of SOPs, WIs, FDA, and local regulations as well as ICH GCP guidelines
• Good command of written and spoken English
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.