Beschreibung
Clinical Research Scientist - 12 months contract -Switzerland (home-based)Our client - global pharmaceutical company has a need for a Clinical Research Scientist to join a new project and support planning, design, scientific monitoring and reporting of clinical studies in compliance with regulatory standards and procedures.
Responsibilities:
responsible for delivering the clinical study protocol and contributes to the development of other clinical study documents, e.g. Informed Consent Form, Case Report Form, etc.
Plans, manages and monitors daily activities of clinical studies which require scientific input, e.g. contribution to answers to trial-related Health Authorities' (HA) questions, answer to Ethic Committees /Institutional Review Boards questions, etc.
Performs medical monitoring/ reporting including evaluation of adverse events.
Reviews, evaluates and reports results of clinical studies.
Manages study-related committees, external medical experts etc.
Ensures that all activities are in compliance with department, company and regulatory standards and procedures.
As requested, contributes to the development and execution of clinical research programs for assigned company products, e.g. Clinical Development Plans, Clinical Overviews, HAs' Briefing Books, HAs' Annual Reports, Pediatric Investigational Plans, etc.
As requested, participates on cross functional teams, e.g. improvement of processes, etc.
Requirements:
Strong experience in Clinical Development, and hands on experience on conducting clinical trials.
Knowledge of clinical development processes, clinical trial processes, and regulatory requirements/ ICH guidelines based on previous deliverables.
Prior experience of working in a matrix organization including interactions with all relevant functions involved in a clinical trial and program (e.g. Biostatistics, Data Management, Operations, Regulatory, Drug Safety, external service providers, etc.).
Good leadership skills.
Demonstrated analytical skills.
Excellent computer systems and software skills.
Excellent English, other languages advantageous.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.