Les offres d'emploi : Professions sociales - Santé ...

You will be able to conduct or manage (external sources):
- CRO conduct of clinical trials
- on-site training of personnel in all aspects of study requirements
- (co) monitoring visits, verifying enrolment, clinical supplies availability, protocol compliance, product accountability and clinical trial data for accuracy and consistency, take appropriate action to resolve disceprancies.
- you will have to ensure that phases I and II are conducted and documented in accordance with applicable (inter)national regulations, GxP and company SOPs.

Activities include:
- compiling of CTA, IMPD, IB, protocol synopses, protocols, design of CRFs, preparation or review of Informed Consent, protocol amendments, interim or final clinical reports, and clinical regulatory documents and follow through regulatory and IRB/EC procedures to allow implementation in a timely manner
- Investigator/Site identification, evaluation and selection
- organisation and/or facilitation of Advisory Board, Pre-Study and/or Investigator Meetings
- development, revision and implementation of SOPs and other working practices
- selection and contracting of external resources Professional and personnal skills

- At least 3 years experience in the pharmaceutical industry
- knowledge of International (EU and US) regulations and GCP/ICH guidelines governing clinical trials
- fluent in english
- autonomous, pro-active, detail orientated


Michael Page...