Beschreibung
We are looking for Clinical Research Scientist with prior experience in the industry in planning, designing, monitoring and reporting clinical studies.RESPONSIBILITIES:
1. delivering the clinical study protocol and contributes to the development of other clinical study documents, e.g. Informed Consent Form, Case Report Form, etc.
2. Planning, managing and monitoring 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.
3. Performing medical monitoring, reporting including evaluation of adverse events.
4. Reviewing, evaluating and reporting results of clinical studies.
5. Managing study-related committees, external medical experts etc.
6. Ensuring that all activities are in compliance with department, company and regulatory standards and procedures.
7. Contributing 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.
8. Participates on cross functional teams, e.g. improvement of processes, etc.
REQUIREMENTS:
1. PhD, PharmD, DVM, MSc (or equivalent) degree in Biological Sciences required.
2. At least 5 years experience in Clinical Development, and hands on experience on conducting clinical trials.
3. Knowledge of clinical development processes, clinical trial processes, and regulatory requirements/ ICH guidelines based on previous deliverables.
4. 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.).
5. Good leadership skills.
6. Demonstrated analytical skills.
7. Excellent computer systems and software skills.
8. Excellent English, other languages advantageous.
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.