Senior Clinical Site Manager
- PAREXEL provides their Clinical Site Managers with world class technology, training resources, and limited protocol load. You will also be rewarded for your hard work through our incentive program and career advancement opportunities.
Your Key Accountabilities:
- Perform all clinical monitoring/site management activities for assigned projects in accordance with PAREXEL's standard operating procedures
- Act as PAREXEL'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 Clinical Site Managers
- 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
- 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 French, with a conversational level of Dutch, OR, competent in written and oral English and Dutch with a conversational level of French
We offer you a fascinating and diversified insight into PAREXEL and an exciting journey through the world of clinical research.
You can expect to work with a successful, highly-qualified and dynamic team as you develop your individual scientific profile. You can also look forward to a flexible working environment and a pleasant atmosphere.
If you are ready to join PAREXEL’s Journey, please apply!