Clinical Research Scientist - Contractor Switzerland -


For a global pharmaceutical company near Neuchatel, we are looking for a Clinical Research Scientist Contractor to support the clinical science team in hematology/oncology studies.


The Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.


Responsibilities:

  • Support the Clinical Scientist team in the extrapolation and review of study data from the investigator sites

  • Responsible for interacting with study sites to review, extrapolate, collect, study data, including, but not limited to, patient diagnosis, treatment plans/regimen, adverse event documentation and reporting, clinical response, and long-term follow-up.

  • May assist with designing data capture worksheets for investigator sites

  • Reviews and verifies source documentation to determine accuracy and completeness of information and communicate discrepancies to clinical team for action resolution.

  • Adhere to standard operating procedures, protocols, and study specific guidelines

  • Provide updates to clinical team as appropriate

  • Participate in job related training and ad-hoc meetings

  • Collaborate and liaise with external partners (e.g., KOLs), as per project needs

  • Seek out and enact best practices with instruction • Provide regular and timely updates to manager/management as requested

  • Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required

  • Conduct literature review

  • Submit clinical documents to TMF

  • Develop site and CRA training materials and present these at SIVs and Investigator meetings

  • Review clinical narratives

  • Monitor clinical data for specific trends

  • Develop Data Review Plan in collaboration with Data Management

  • Ensure CRF design 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.)

Requirements:

  • Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or scientific field preferred).

  • Oncology experience (preferred). Experience in an oncology clinical research or hospital setting.

  • Hematology experience (preferred)

  • 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 commitment to quality

  • Basic knowledge of disease area, compound, 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)


Candidates must have the right to work in Switzerland e.g. Swiss/EU nationality and/or current Swiss work permit holders.

Please contact recruitment@consultantsinscience.com to appl or for more information