Beschreibung
Harvey Nash is looking for an Expert Clinical Manager for a 6 month project in Switzerland.
The role is for a candidate who is responsible for all operational aspects of 1 or more OGD clinical trial(s) under the leadership of Clinical Trial Head (CTH) and supporting all scientific aspects of clinical trial(s) as assigned. S/He is also responsible for program level activities as assigned.
You are responsible for
Ensuring all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards Providing input and contribute to the development of protocols and related documents, in the ongoing scientific review of clinical data, and in trial data analysis, reporting and publishing Preparing training materials and presentations related to the planning and conduct of the trial Preparing clinical outsourcing specifications and for management of Contract ResearchOrganizations ( CROs) and ensuring adherence to scope of work within timelines and budget Managing interactions with Oncology Development Operations and other relevant functions including Drug Supply Management and clients' local medical organizations. accuracy of trial information in all trial databases and tracking systems Supporting the development, management and tracking of trial budget working closely with the appropriate partners in OGD Participating in the organization and logistics of various oversight and Advisory boards; attending meetings managing/answering questions related to trial procedures and patients' eligibility Writing CTT meeting minutes Contributing to program level activities (eg, tracking of OGD program-related publications, development of clinical sections of regulatory documents like Investigators' Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions) implementation of best practices and standards for trial management within the TA, including sharing lessons learned Contributing to talent and career development of OGD staff through active participation in on- boarding, training and mentoring activities. Requirements
Advanced degree or equivalent education/degree in life science/healthcare required accompanied with = 2 years experience in clinical research or Bachelor degree or equivalent education/degree in life science/healthcare required if accompanied with = 4 years experience in clinical Involvement in cross-functional, multicultural and international clinical trial teams; demonstrated capabilities in leading specific trial related activities like planning, executing, reporting and publishing activities Excellent communication, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines Knowledge of Good Clinical Practice; thorough knowledge of clinical trial design; understanding of the overall drug development process Knowledge of principles for trial budgeting Basic knowledge of oncology and/or hematology preferable Fluent English (oral and written) Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred)
