לוח אפשרויות קריירה - הדרך החכמה להייטק

a global biotech company is looking for clinical researcher
Responsibility
Participation and support in the following tasks:
Participation in clinical development processes of innovative and breakthrough products, including promotion of new ideas and supporting the work from planning to execution.
Conducting feasibility studies for new ideas, conducting comprehensive research in professional literature while collecting information, identifying indications, cross-referencing data and drawing conclusions
Involvement in planning and management of clinical trials, in Israel/EU/US, to assure data integrity, compliance with SOPs, local regulations, and VICH-GCP guidelines as well as other applicable regulations, to ensure safety and wellbeing of study subjects.
Participation in the design, writing and review of protocols, study reports, clinical SOPs, and other related clinical documents in accordance with regulatory bodies (such as FDA, EMA) requirements.
support to the clinical operations teams, oversight of CRO and vendor activities, with regards to operations per protocol/plan, timelines and adherence to the agreement.
Managing regulatory authority applications and approvals of clinical study documents.
Collaboration with statisticians and data management team on statistical analyses, data management plan, and reports.

דרישות:
Mandatory requirements
MSc/PhD/ equivalent degree in a health or life science related field
Previous experience of at least 2 years in managing clinical research, including experience in veterinary or human Phase 1-4 studies (with emphasis on Phase II-III studies experience)
Fluent business English – speaking, writing and reading

Significant advantage

DVM
PhD in Epidemiology