As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Did you know?
Labcorp's Clinical Development and Commercialization Services business is now Fortrea in connection with its planned spin-off from Labcorp, which is expected in mid-2023. Fortrea’s spin-off from Labcorp is subject to satisfaction of certain customary conditions. This spin-off will position both organizations for accelerated growth and allow each to focus resources on distinct strategic priorities, customer and employee needs and value creation opportunities. As a provider of phase I-IV clinical trial management, regulatory guidance, patient access solutions and market access consulting, Fortrea will partner with both emerging and large pharmaceutical, biotechnology, device and diagnostic companies to drive healthcare innovation and improve the lives of patients worldwide.
Fortrea is looking for problem-solvers and creative thinkers who are passionate about breaking down barriers faced by sponsors of clinical trials, and who are committed to helping transform the development process to get promising life-changing ideas and therapies to patients faster. Join us as we cultivate a workspace where all employees have the opportunity to grow and make impacts on a global scale. For more information and questions related to Fortrea, please visit www.fortrea.com.
We are currently looking for Country Clinical Quality Manager to be based in Greece. This tole will be dedicated to sponsor.
The role requires the ability to properly implement local/global processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives. In addition, the CCQMs support audits, inspections as well as Quality Control and local training activities.
CCQM identifies local as well as global process improvement opportunities and training needs, and will be the local point of contact for all stakeholders ensuring appropriate training is implemented
Key responsibilities:
Local expert for ICH-GCP and local regulations (incl. impact assessment of new/updated local regulations on local processes).
Local expert for any quality related issues
Local training point of contact
Perform local QC activities and conducts ad hoc site visits upon request
Primary point of contact for Regulatory Agencies
Manages and supports activities during the preparation/ongoing/follow-up phase of an audit and inspection
Responsibility for the management of the Client Corrective and Preventive actions (CAPA) of GCP audits and inspections in the country/US region at the Client level according to the Client Standard Operating Procedures and ICH Guidelines and GCP
Communicates/escalates quality/compliance issues (incl. any potential trends) to local country operations management
The role requires the ability to follow current processes and procedures of the Client but also the ability to improve processes and procedures
Key requirements:
Minimum of six-eight (6-8) years of clinical research monitoring experience (including prestudy, initiation, routine monitoring and closeout visits) ¨
Deep knowledge and understanding of Clinical Trial processes and quality management tools
Demonstrated experience leading cross-functional teams of business professional
Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results
Excellent site monitoring skills
Excellent study site management skills
Ability to work with minimal supervision
Good planning and organization skills
Good computer skills with good working knowledge of a range of computer packages
Excellent verbal and written communication skills ¨ Ability to train and supervise junior staff
Ability to resolve project-related problems and prioritizes workload for self and team
Ability to work within a project team
Works efficiently and effectively in a matrix environment
Labcorp is proud to be an Equal Opportunity Employer:
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