Clinical Research Scientist
- Experience Level
- Experienced (non-manager)
Hobson Prior are looking for a Clinical Research Scientist to join a world-wide biopharma organisation focused on improving the lives of patients globally through pioneering medicines. This is a contract position based in Switzerland.
- Co-operate and liaise with external partners (e.g., KOLs, CROs).
- To provide regular and timely updates to manager/management as requested.
- Conduct literature review.
- Develop Protocol and ICF documents / amendments (writing, reviewing, amending and cross-functional facilitation as appropriate).
- Submit clinical documents to TMF.
- Support the development of site and CRA training materials and present these at SIVs and Investigator meetings.
- Review clinical narratives.
- Review of 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.
- Must be able to function independently and remote, as required.
- Detail-oriented with commitment to quality.
- Basic knowledge of disease area, compound, current clinical landscape.
- Intermediate critical thinking and problem-solving skills.
- Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools).
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred).
- Hematology/Oncology experience (Cell Therapy preferred) in a clinical research and development, in a clinical science capacity, ie not laboratory or bench science.
- Basic 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.
- Familiarity with Medidata, RAVE, J-review or other clinical databases or other data review tools (patient profiles, listings).
- Experience performing data review in hematology/oncology indications highly preferred.
- Intermediate medical writing skills and medical terminology.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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