Olivier Gourvénec

Ensure that systems and processes for Global and European clinical management activities comply with appropriate regulations, standards and corporate requirements
1- Interact with the Global QA Lead, Global Clinical Operational Lead, Regional Heads for Western and Europe Clinical Operations
2- Provide consulting services for local and regional heads of clinical operations, clinical team leaders and monitors
3- Regularly review processes/standards, quality metrics and quality issues with regional executive directors
Develop, implement and manage European program of office audits (2006 – I managed a team of 5 auditors assessing 27 offices, 240 operational staff, 60 projects contracted by 29 sponsors) and global programs of system audits for project start-up and monitoring management activities
4- Develop, implement and manage global program of quality training courses (2007 – I managed a team of 9 auditors who delivered 58 courses thus training 794 operational staff)
5- Represent QA on global working parties developing innovative clinical operation processes and tools
6- Interact with European and Global network of clinical operation quality champions
7- Evaluate and assist with the management of subcontractors, process engineering and risk management
8- Manage all type of national and international GCP regulatory inspections

Sector: Health and pharmaceutical

Quintiles is the world leading Clinical Research Organisation present in more than 50 countries. From early development through late-phase trials, Quintiles offers the entire range of integrated product development services you need. No matter where your point of entry in to our resources, Quintiles will craft a customized program providing seamless access to our full range of development services to meet your specific needs.

Worldwide Quality Services Executive for Access to Patient Dpt:
1- Providing worldwide quality support and training courses to this emerging service, devoted to clinical trial patient recruitment and investigator’s relationships (i.e. site management organisation, call centre)
2- Developing and managing (coordinating a group of auditors) worldwide auditing program targeting systems in place at preferred patient recruitment organisations (in Europe – 8 SMOs, 28 Secondary care sites, thousands of Primary care sites; in the US – 12 SMOs)
3- Conducting system audits and providing support for regulatory inspections on ATP activities

European Quality Services Executive for Clinical Operations Dpt:
1- Ensuring that systems and process for clinical management activities comply with appropriate regulations, standards, corporate and contractual requirements
2- Regularly reviewing processes/standards, quality metrics and quality issues with executive directors
3- Developing and managing European program of office audits (e.g. 27 offices audited in 2005-2006 in Europe)
4- Developing and managing European quality training courses (in 2006, 27 courses with 453 monitors trained – in 2007, 65 course planned)
5- Providing consulting services for local heads of clinical operations, clinical team leaders and monitors
6- Interacting with a network of 9 clinical quality managers spread across Europe
7- Evaluating and assisting with management of subcontractors and Clinical Operation process engineering

Sector: Health and pharmaceutical

Quintiles is WW leading clinical research organisation. With more than 17000 employees located over more than 50 offices worldwide. Quintiles offer a wide range of services for pharmaceutical industry from pre-clinical to commercialisation - see www.quintiles.com


Worldwide Quality Services Executive for Access to Patient Dpt:
1- Providing worldwide quality support and training courses to this emerging service, devoted to clinical trial patient recruitment and investigator’s relationships (i.e. site management organisation, call centre)
2- Developing and managing (coordinating a group of auditors) worldwide auditing program targeting systems in place at preferred patient recruitment organisations (in Europe – 8 SMOs, 28 Secondary care sites, thousands of Primary care sites; in the US – 12 SMOs)
3- Conducting system audits and providing support for regulatory inspections on ATP activities

European Quality Services Executive for Clinical Operations Dpt
4- Ensuring that systems and process for clinical management activities comply with appropriate regulations, standards, corporate and contractual requirements
5- Regularly reviewing processes/standards, quality metrics and quality issues with executive directors
6- Developing and managing European program of office audits (e.g. 27 offices audited in 2005-2006 in Europe)
7- Developing and managing European quality training courses (in 2006, 27 courses with 453 monitors trained – in 2007, 65 course planned)
8- Providing consulting services for local heads of clinical operations, clinical team leaders and monitors
9- Interacting with a network of 9 clinical quality managers spread across Europe
10-Evaluating and assisting with management of subcontractors and Clinical Operation process engineering

Sector: Health and pharmaceutical