Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. We have a vacancy for a Clinical Logistics Monitor in our Global Clinical Supplies team based in France. A day in the life: Performs site management and other related activities on assigned Cell & Gene Therapies projects in accordance with the approved protocols, ICH-GCP, GMP and GDP guidelines, applicable regulations and the organization's SOPs. Serves as a central point of contact focused on communication, site training, patient sample management, logistics (collection/shipments), analysis, and data management to provide seamless integration across patients, clinical sites/investigators, manufacturers and logistics partners. The primary role is to coordinate the process of the clinical cellular material from harvest/production to infusion between the sponsor, manufacturer, logisitcs vendors and investigator sites while ensuring that the chain of identitiy and chain of custody are intact in order to protect the patient's safety. Acts as the primary point of contact for all clinical sites and the sponsor(s). Remote role which oversees recruitment and slot allocation on the study. Trains, supports and manages study sites, from site qualification through patient enrolment. Acts as lead support for Mock Run activities for cellular material harvest and patient sample/ IP shipments. Provides clinical site personnel training including refresher training on logistics activities. Oversees and coordinates the collection, processing, shipment to/from the manufacturing site and return of the patient’s cells for infusion including quality review and distribution of all forms. Oversees the material inventory (e.g., tumor harvest reagents and laboratory kits, co-therapy supplies etc. ) at the site(s) and coordinate re-ordering as necessary. Tracks all samples and potential patients via the organization systems or sponsor systems (if possible) or tools developed specifically for the sponsor and the study (i.e. vendor platform or cellular tracking flow sheet). Liaises closely with all internal and external stakeholders, including Sponsor, investigator sites, Medical Monitor, the organization's Central Labs (or outsourced vendor), the organization's Project Delivery Lead, CMO and shipping/logistics vendor. Assists with projects as assigned Keys to success Education and experience: Bachelor's degree in a science-related field or Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Previous experience of clinical trials and site monitoring, 2+ years that provide knowledge, skills, and abilities to perform the job. This includes experience working with clinical sites and familiarity with patient sample management, logistics processes (collection/shipments) associated with the IP. Cell & Gene Therapy experience preferred but not mandatory. In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: Good medical/therapeutic area knowledge and solid understanding of medical terminology Understanding of trial climate and ability to predict outcomes Ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and the organization's procedural documents Ability to advise, train and mentor investigational site personnel Excellent English and communication skills, both written and verbal Excellent communication, organization skills and attention to detail Pro-active, ability to prioritize and work in a fast-paced environment Willingness to learn and adapt Ability to multi-task Ability to work in a team and independently Demonstrated leadership and delegation skills Excellent independent problem solving skills Strong working knowledge of MS Office and ability to learn and use appropriate software Travel to site approximately 50% of time across France Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.