CDD - Human Trials Manager (F/H/NB)
Bayer · Gaillard, Auvergne-Rhône-Alpes, FR
CDD - Human Trials Manager (F/H/NB) Purpose : - Organise the supply of prototypes intended for human trials, predominantly Dermatology category. - Ensure Rol...
Job description
CDD - Human Trials Manager (F/H/NB) Purpose : - Organise the supply of prototypes intended for human trials, predominantly Dermatology category. - Ensure Roll-out and training as needed of Human Trials procedure across the site. - Review and update documentation and procedures linked to Human Trials. Scope: Global: Key Tasks: Coordination of Human Trials Supplies Lead the Coordination Efforts: - Oversee the timely and quality provision of prototypes for all types of human trials, ensuring alignment with study timelines and requirements, including manufacturing, packing, labelling and shipping & controlled delivery to study site to ensure the tests samples are produced according to cGMP. - Establish required documentation with 3rd parties and establish or assist in writing manufacturing & labelling instructions for internal operations. - Collaborate with Cross-Functional Teams: Work closely with R&D, clinical operations, and other relevant departments to gather trial requirements and ensure seamless supply chain operations. - Quality Assurance: Establish and maintain quality standards for prototypes, ensuring compliance with relevant regulations and internal policies. SOP Review and...