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CK Group are working with a commercially successful, privately owned biotech company, who are developing radiolabelled compounds for Oncology imaging and treatment. They are soon to begin their first Phase I study, and are looking for a permanent Clinical Study Manager to support this.

This will be a fully home-based role, in either the UK or Germany.

RESPONSIBILITIES :

As Clinical Study Manager you will be an integral part of the Clinical Operations team, project managing Phase I & II studies against agreed milestones.

Key duties will include :

• Leading the clinical study team and ensuring delivery of studies within agreed timelines and budgets.
• Maintaining high quality and effective monitoring function and productive site relationships through the respective CROs and other vendors to ensure effective delivery and oversight.
• Preparation of key study documents such as protocols, amendments, informed consents, study procedure manuals, eCRFs, analytical plans, and other study documents through discussion with internal and external partners.
• Contribution to and review of documents for IMPDs / IBs / Protocols / CTAs / INDs and relevant regulatory section submissions.
• Through external partners, manage the study budget, timelines, study conduct and close out including involvement in the management of clinical trial material, which includes accurately projecting enrolment to ensure continuity of supply.
• In conjunction with the quality function, coordinate audit strategy / plans to ensure all clinical trial activities meet quality requirements including GCP, ICH, TGA, MHRA, EU and FDA guidelines and regulations as appropriate.

QUALIFICATIONS :

As Clinical Study Manager you will require :

• Proven clinical operations experience gained with Phase I & II Oncology trials.
• Extensive, industry-based experience of working in a GCP environment.
• Experience of managing clinical trial supplies.
• Experience of the selection and management of CROs and other suppliers.

BENEFITS :

Salary up to 85,000.

Apply :

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 124 234 in all correspondence.