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Senior Clinical Scientist
Vue: 139
Jour de mise à jour: 21-03-2024
Catégorie: Autre
Industrie: Pharmaceutical Manufacturing
Niveau: Associate
Type d’emploi: Full-time
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le contenu du travail
As our new Senior Clinical Scientist, you will participate in creating the clinical strategy, design of clinical trials as well as creating documents supporting the scientific aspects of the clinical study and contributing to the clinical study report.
Job Responsibilities
- Assist with organizing, managing and conducting Scientific Advisory Boards and KOL reviews
- Develop, research and maintain current and future competitive clinical landscape(s)
- Identify clinical thought leaders within the appropriate therapeutic area to establish relationships and provide scientific outreach within the dermatological specialty community
- Coordinate study design and Protocol development with team members to address scientific questions
- Own scientific aspect/rationale of the protocol (i.e. methods, scales, labs, etc.) and contribute to clinical section of development plan and/or protocol(s) in collaboration with other clinical study team members
- Coordinate with team members to address scientific questions related to planned or ongoing clinical trials, in liaison with relevant staff at CRO(s) and vendors as applicable
- Contribute to the selection of vendors, countries and trial investigators
- Support the development of the Clinical Study Report (CSR), in collaboration with the scientific writer or others
- Contribute to the preparation of regulatory documentation (Briefing Packages, Investigator’s brochures, IND/IMPD, labelling documents etc.), and answer to questions from Health Authorities during the review process etc.
- Prepare and review SOPs, and contribute to process improvement initiatives, as deemed appropriate
Minimum Requirements
- Seven (7) or more years of relevant experience in clinical research and development in the pharmaceutical industry and/or in a Contract Research Organization (CRO)
- Experience in the scientific aspects of design and conduct of large and/or complex phase 2/3 clinical trials is preferred
- Fluency with GCP and ICH guidelines
- Bachelor’s degree in Life Sciences, Engineering or related field (Master’s degree, PhD or Medical Doctor, preferred)
- Proven experience in supporting development of systemic agents (large or small molecules)
- Experience in presenting to a scientific audience
- Proficient in MS Office applications
- Fluent in English (written and oral)
- Good knowledge in MS Office applications
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Date limite: 05-05-2024
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