The company
Our client is a global pharmaceutical company located near Neuchatel, Switzerland
Focused on research and clinical development of innovative medicines across several therapeutic areas, including oncology, hematology and immunology.
Flexible working: 1-2 days office-based and the rest home-based.
The Role
Our client is looking for a clinical scientist to join their clinical science team. The clinical scientist will be responsible for designing and executing assigned clinical trial activities and working closely with clinical team members within the assigned project to execute activities. Activities may include:
collaborating and liaising with external partners (e.g., KOLs)
developing Protocol and ICF documents/amendments and presenting these to governance committee and development team meetings as required
conducting literature review
submitting clinical documents to TMF
developing site and CRA training materials and presenting these at SIVs and Investigator meetings
reviewing clinical narratives
monitor clinical data for specific trends
developing data review plan in collaboration with Data Management
ensuring CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming
submitting 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 contributing to regulatory submission.)
You
If you are interested in this role, the client is looking for someone with the following background:
Degree in Life Sciences (MD, PhD, Pharm D, MS, RN, or another scientific field preferred). Appropriate for a new entrance to pharma (post-fellowship/ new to the industry)
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
Intermediate medical writing skills and medical terminology
Basic planning/project management skills (develop short-range plans that are realistic and effective)
Detail-oriented with a commitment to quality
Basic knowledge of disease area, compound, and current clinical landscape
Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
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., Patient Profiles, report generating tools)
***This position has now been filled, please contact recruitment@consultantsinscience.com to be informed of future similar positions***