Purpose of the internship:
Contribute to the development of a quality system oriented ‘clinical operation’ within an industry group specializing in nutrition and health.
Internship description:
Under the direction of the Substantiation Plan Manager, you will participate in the determination of the main short-term objectives in terms of quality management of clinical operations. You will implement the response to these objectives through the drafting of standardized procedures, standard document templates (e.g. investigation protocols and plans, Investigator Brochure) and support to teams on the coordination of ongoing, in preparation and future processes.
Furthermore, you will have the opportunity to support the validation and application team in its activities, in its internal relations (knowledge management, scientific oversight, support to marketing, sales, regulatory teams, relations with other R&D teams of the group) and external (qualification/selection of service providers, investigative centres, competent authorities and ethics committees).
Main activities :
- Participation in the determination of short-term objectives in terms of quality management of the clinical interventions promoted by the group;
- Drafting of standard operating procedures (SOP) and operating methods (MOP) that frame the implementation of clinical trial projects;
- Preparation of standard document templates;
- Support teams in managing current and future clinical trial projects.
Secondary activities:
- Participation in the development of internal training materials (workshops) related to clinical operations;
- Contribution to knowledge management on the business unit portfolio products.
