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Clinical Scientist, Early Development
vor 2 Monaten
We are looking for our client, international pharmaceutical company based in Boudry, a Clinical Scientist, Early Development for a 6 months contract, starting 8th of January 2024.
- Collaborate and liaise with external partners (e.g., KOLs).
- Seek out and enact best practices with instruction.
- Provide regular and timely updates to manager/management as requested.
- Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required.
- Conduct literature review.
- Develop site and CRA training materials and present these at SIVs and Investigator meetings.
- Review clinical narratives.
- Collaborate cross-functionally to monitor clinical data for specific trends.
- Contribute to the development of Data Review Plan in collaboration with Data Management.
- Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
- Author/review clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., Pre-IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)
- Submit clinical documents to TMF.
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred).
- Expectation of 2+ years of experience in clinical science, clinical research, or equivalent.
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
- Ability to understand assigned protocol(s) and their requirements.
- Knowledge and skills to support program-specific data review and trend identification.
- Intermediate medical writing skills and medical terminology.
- Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
LI-Hybrid
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Clinical Scientist, Early Development
vor 2 Wochen
Basel, Schweiz Adecco VollzeitWe are looking for our client, international pharmaceutical company based in Boudry, a Clinical Scientist, Early Development for a 6 months contract, starting 8th of January 2024. - Collaborate and liaise with external partners (e.g., KOLs). - Seek out and enact best practices with instruction. - Provide regular and timely updates to manager/management as...
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