Contract Clinical Trial Manager

CK Group are 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 reports.

QUALIFICATIONS:

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.
• Phase III Oncology experience is essential.

BENEFITS:

Competitive day rate.

Apply:

Please quote job reference 106927 in all correspondence.