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Clinical Trial Manager
2 months ago
Job Summary:
Clinical Trial Manager - Oncology
About CK Group:
CK Group is a leading provider of scientific, clinical, and technical services to the pharmaceutical and biotechnology industries.
Job Description:
We are seeking an experienced Clinical Trial Manager to join our team in a contract role. The successful candidate will have a strong background in clinical trial management, with a focus on oncology.
Responsibilities:
- Lead cross-functional study teams to ensure successful clinical trial implementation and protocol execution.
- Manage and oversee the activities of Contract Research Organizations (CROs) and other clinical vendors.
- Ensure that all study activities are carried out in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP), Health Authority regulations, and company Standard Operating Procedures (SOPs).
- 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.
- Phase III oncology experience is essential.
What We Offer:
- Competitive day rate.
