Clinical Trial Manager

The PositionReporting 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.Tasks & Responsibilities

• 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

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

What we offerBoehringer Ingelheim offers a competitive remuneration, attractive bonus scheme, health insurance, employee assistance program, development programs and career development opportunities.We want the best to applyBoehringer Ingelheim is a global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and foster an inclusive environment which benefits our people, patients, and communities.How to applyIf you would like to be part of this highly driven and successful team, please submit your CV and a covering letter addressing the key criteria above. You must have the right to live and work in this location to be considered for this opportunity.Thank you for taking the time to consider a career opportunity with Boehringer Ingelheim. As part of our efforts toward continuous process improvement, you may receive a short survey pertaining to this recruitment process. We really appreciate your honest feedback. Thank you.It is Boehringer Ingelheim's policy not to accept speculative resumes from Agencies unless the role has been released directly to the agency. If we require your assistance on any roles, we will contact you at the time.Position AreaHuman PharmaPosition LocationNSW - SydneyOrganizationBI - AustraliaScheduleFull Time#LI-BI