Remote - Swiss based - Clinical R&D
Support ongoing phase III studies with your expertise as Scientist for Clinical Trails! Top-notch therapy Immuno-Oncology Cellular Therapy study. The Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.
- Responsible to support the execution of assigned clinical trial activities
- Close collaboration with clinical team members within the assigned project
- Support Clinical Trial Lead for one or more trials
- lead or support trial level activities for one or more trials with the necessary supervision
- co-lead study team meetings and collaborate with cross-functional study team members
- degree in Life Sciences (MD, PhD, PharmD, MSc)
- > 2y direct indication experience in Clinical Research, Development or Clinical Science
- Knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
- Ability to understand assigned protocol(s) and their requirements
- Basic knowledge skills to support program-specific data review and trend identification in safety or efficacy.
- Experience in data review in hematology/oncology indications is an asset.
You will collaborate and liaise with external partners (e.g., KOLs, CROs) and develop Protocol and ICF documents / amendments (writing, reviewing, amending and cross-functional facilitation as appropriate). You conduct literature review and submit clinical documents to TMF. You support the development of site and CRA training materials and present these at SIVs and Investigator meetings. Your review clinical data within eCRF system, patient profiles, etc. to issue queries and clean data from clinical perspective, ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming. Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission where applicable. Experience with CAR-T not required but a plus!
Our customer is an innovative biopharmaceutical Big Pharma company specialized in Hematology-Cell Therapy with an attractive international portfolio of marked products, R&D activities are successfully ongoing and several drug candidates are in clinical development at different stages.