Responsible for the oversight of the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). Act as one of the points of contact at a Site level for internal and external stakeholders.
Requirements
- Bachelor's degree required preferably within life sciences or equivalent.
- 2-3 years of relevant clinical research experience, able to work independently.
- At least 5 years of monitoring experience. Demonstrate leadership skill, mentor and coach capability.
- Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator preferred.
- Experience in the drug discovery/development process.
- Good verbal and written communication skills (both in English and local language). For English, OPA Score >4 or business level ability to interact with the stakeholder.
- Microsoft Suite
- Able to work with Clinical Trial Management Systems (CTMS)
- Software that must be used independently and without assistance (Microsoft Suite, Clinical Trial Management Systems (CTMS), Electronic Data Capture Systems (eDC); Electronic Trial Master File (eTMF), Metrics Websites)
Benefits
- Competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.