Hobson Prior are looking for a Clinical 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 where you will be required to work remotely.
- Co-operate and liaise with external partners (e.g., KOLs, CROs).
- Develop Protocol and ICF documents / amendments (writing, reviewing, amending and cross-functional facilitation as appropriate).
- To provide regular and timely updates to manager/management as requested.
- Conduct literature review.
- 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 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.
- Ability to function independently and remote, as required.
- You are detail-oriented with commitment to quality.
- Intermediate critical thinking and problem-solving skills.
- Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism).
- 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).
- Basic knowledge of disease area, compound, current clinical landscape.
- 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 protocols 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