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Jim Gleeson at the CK Group is working with a clinical-stage biotechnology company who specialise in oncology to secure a contract Clinical Trial Manager. The company have an excellent pipeline of truly exciting and groundbreaking medicines across early phase development. Reporting to the Associate Director, Clinical Operations you will have responsibility for facilitating activities to ensure successful clinical trial management and execution of the company’s clinical programs.

This role will be for six months initially.

RESPONSIBILITIES:

As Clinical Trial Manager you lead cross-functional study teams to ensure successful clinical trial implementation and protocol execution.

Manage and oversee the activities of CROs and other 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 reportsQUALIFICATIONS:

As Clinical Trial Manager you will require:

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 essentialBENEFITS:

Competitive day rate

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