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.Job Overview:• Responsibility for the annual country specific QC plan, monitoring, and coordinating the implementation, and execution of QC plan in the respective country/US region according to the Client Standard Operating Procedures and ICH Guidelines and GCP.• 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.• Responsibility for the annual country specific quality plan, monitoring, and coordinating the implementation and execution of QC in the respective country/region.• Responsibility to manage and/or co-lead key Client initiative charged with executing the continuous improvement.• 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. The role requires the ability to follow current processes and procedures of the Client but also the ability to improve processes and procedures.• This position has a significant impact on the ability to conduct clinical trials in accordance with external and internal regulations and guidelines of the Client.Summary of Responsibilities:On the Client level:• ICH Guidance and GCP Regulations, Country Client SOPs: Is an expert at local level. Local Lead for Management of the Client Country Standard Operation Procedures (CSOP).• In cooperation with country functional area heads: ensures the Client CSOPs are checked /updated regularly; signs/authorizes CSOP deviations along with process owner.• Responsible for all aspects of the quality site management as prescribed in the project plans.• Local Quality and Process Improvement and training contact person- identifies local training demand, initiate local training needs and activities.• Defines an annual country QC plan with collaboration to regional CQM.• With mutual agreement with the functional areas will perform quality control (QC) activities and visits. Support on resolution of quality issues.• Responsible for management and support audit preparation activities. In cooperation with country functional area person initiate state of the art root cause analysis for audit and inspection findings.• Responsible for country trend analysis and impact assessments of audits and/or inspection findings.Qualifications (Minimum Required):• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.• In lieu of the above requirement, candidates with six (6) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.• Thorough understanding of the drug development process.• Fluent in local office language and in English, both written and verbal.Experience (Minimum Required):• 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.Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
