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Clinical Trial Manager
2 months ago
Job Summary
The CK Group is working with a clinical-stage biotechnology company specializing in oncology to secure a contract Clinical Trial Manager. The company has an excellent pipeline of truly exciting and groundbreaking medicines across early phase development.
Key Responsibilities
- Lead cross-functional study teams to ensure successful clinical trial implementation and protocol execution.
- Manage and oversee the activities of clinical vendors.
- Ensure that all study activities are carried out in full compliance with ICH GCP, Health Authority regulations, and company SOPs, and maintain inspection readiness.
- Manage ongoing study communication and escalation of study-related issues as required.
- Write and develop study documentation, such as Protocols, Investigator Brochures, and Informed Consent Forms.
- Participate in the review and approval of clinical monitoring visit reports.
Requirements
- Extensive clinical trial management experience gained in an industrial environment.
- An in-depth knowledge of ICH, GDP, and FDA requirements.
- Excellent interpersonal and collaborative working skills.
- Oncology experience (ideally early phase) is essential.
Benefits
Competitive day rate.