Clinical Trial Manager

at  BI Australia

THE POSITION

Reporting to the Clinical Research Manager (CRM), we have an exciting opportunity for a Clinical Trial Manager to be based in Head Office at Macquarie Park.
The Clinical Trial Manager (CTM) is responsible for local-level trial management activities for BI trials conducted in Asia Pacific region. The role will lead studies in accordance with the protocol, ICH-GCP guidelines, corporate SOP’s as well as applicable regulatory requirements.
The CTM is a key liaison between internal and external stakeholders to drive trial feasibility, execution, and overall therapeutic area development strategies.

REQUIREMENTS

• Tertiary qualifications in biological, health or medical sciences, pharmacy, nursing, or medicine
• Postgraduate qualifications highly regarded
• 4-6 years research experience along with project management experience and 2+ years’ experience as a CRA in Australia / New Zealand or demonstrated functional knowledge of local regulations if equivalent international experience
• Project Management / Leadership experience - Experience leading a clinical project team consisting of internal and external stakeholders

• Lead drug development plan input projects, conduct trial feasibility and site selection through cross functional and external expert engagement
• Lead trial start up activities including budget negotiation and forecasting
• Coordinate ethics and regulatory submissions
• Facilitate conduction of recruitment activities
• Liaise with vendors when required
• Assess trial team resources and ensure CRAs working on assigned trials are trained and conducting monitoring in accordance with trial and company requirements
• Ongoing oversight of trial operations during recruitment and maintenance phases
• Actively participate in global teleconferences and meetings as required
• Arrange and conduct regular local team meetings to align overall trial objectives
• Maintain and review Corporate Clinical Trial Management System with timely entry of information and periodic reviews
• Oversee Investigator Site File (ISF) and Trial Master File (TMF) activities conducted by CTA and CRA, through regular TMF completeness checks
• Prepare for and participate in trial audits and inspections
• Successfully execute Trial close-out activities