The Clinical Project Manager will assist in the clinical documentation of Galderma Aesthetics products in accordance with the companys quality system, international standards and regulatory requirements. This position is responsible for execution of clinical studies throughout the development life cycle and provides clinical research expertise to development projects, regulatory submissions and post-marketing clinical studies.
- Develop and compile clinical strategies
- Compile study protocols, investigator brochures and study reports or co-ordinate their production
- Compile clinical documentation to support regulatory submissions or co-ordinate their production
- Manage the clinical scope of study preparation and conduct
- Serve as the primary contact with CRO and act as team leader of the study working group
- Perform literature surveillance.
- Develop and review publications and abstracts
- Represent Clinical Development in project teams
- Participate in the development and improvement of working instructions and routines
Travel & Residency
Fort Worth, TX Five or more years of thorough experience in clinical research
- Five or more years of thorough experience in medical writing
- Experience from all parts of the clinical trial process, from protocol development to the compilation of study reports.
- Experience in compiling clinical documents to registration dossiers e.g. STED, CTD, PMA.
- Experience in supervising and managing CROs.
- Experience as clinical project manager of clinical studies in major market(s) such as US, China.
- Experience in doing presentations to a scientific audience.
- Experience with medical device studies and/or biologics
- Good knowledge in MS Office applications
Associated topics: advertising, brand manager, brand marketing, manage, market, marketing, marketing specialist, product development, product marketing, supply chain