Senior/Clinical Site manager

Proclinical are recruiting for a Senior/Clinical Site manager to work at a leading multinational contract research organisation in Brussels. This is an excellent company to work for, whose clients include many of the world's leading pharmaceutical and medical device companies and they employ over 15,000 personnel in over 50 countries.

Job Responsibilities:

• Perform all clinical monitoring/site management activities for assigned projects in accordance with the company's standard operating procedures
• Act as the company's direct contact with assigned clinical sites, and use judgment to assess and ensure overall integrity of study implementation, as well as adherence to study protocol
• Conduct qualification visits (QV), site initiation visits (SIV) and monitoring visits (MV) at assigned clinical sites
• Good knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Function as a mentor and role model for other CRA team members
• Manage clinical monitoring activities, including:
• Arranging on-site visits and logistics
• Establishment of a site recruitment plan in collaboration with site staff during QV
• Monitoring completeness and quality of Regulatory Documentation
• Performing site documentation verification
• Data collection and drug accountability in accordance with ICH GCP guideline
• Monitoring patient safety on-site and addressing any violations in a timely manner

Skills and Requirements:

• Minimum 2 years of monitoring experience in clinical research
• Educated to degree level (biological science, pharmacy or other health related discipline)
• Strong working knowledge of EDC systems and IVRS
• Experience of CTMS preferred
• Competent in written and oral English and Dutch, with a minimum of conversational level in French OR Competent in written and oral English and French, with a minimum of conversational level in Dutch

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Theodora Savlovschi-Wicks on +44 203 7520 314 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.