CK Group are working with a clinical-stagebiotechnology company who specialise in oncology to secure acontract Clinical Trial Manager. The company have an excellentpipeline of truly exciting and groundbreaking medicines acrossearly phase development. Reporting to the Associate Director,Clinical Operations you will have responsibility for facilitatingactivities to ensure successful clinical trial management and ofthe company’s clinical programs.
Thisrole will be for six months initially.
RESPONSIBILITIES:
As Clinical Trial Manager you lead cross-functional study teams toensure successful clinical trial implementation and protocol.
* Manage and oversee the activities ofCROs and other clinical vendors.
* Ensure thatall study activities are carried out in full compliance with ICHGCP, Health Authority regulations and company SOPs and maintaininspection readiness.
* Manage ongoing studycommunication and escalation of study-related issues asrequired.
* Write and develop studydocumentation, such as Protocols, Investigator Brochures andInformed Consent Forms.
* Participate in thereview and approval of clinical monitoring visitreports.
QUALIFICATIONS:
AsClinical Trial Manager you willrequire:
* Extensive clinical trialmanagement experience gained in an industrialenvironment.
* An in-depth knowledge of ICH, GDPand FDA requirements.
* Excellent interpersonaland collaborative working skills.
* Phase IIIOncology experience isessential.
BENEFITS:
Competitive dayrate.
Apply:
Pleasequote job reference 106927 in all correspondence.