Senior Clinical Project Manager

Work type:  Full time permanent
Location:  Sydney, NSW (Hybrid)

About the role

This is an exciting and dynamic role in a high-growth clinical-stage business. It provides the opportunity for significant career progression and experience across all aspects of clinical trial management.

As a Senior Project Manager, you’ll play a pivotal role in managing multi-centre studies from project initiation to closure. You will report to our highly experienced Head of Clinical Operations, who will provide oversight and support your career progression.

Your responsibilities include leading and managing the clinical team and cross-project, cross-functional project teams and external CROs/vendors to ensure quality execution of assigned Amplificare clinical studies on time, and within budget.

This is a hybrid role with flexible working arrangements. The company operates out of a Sydney CBD office. 

To thrive in this role, you’ll need

  • Experience in clinical monitoring and project management
  • Good understanding of ICH-GCP, and relevant local regulations
  • Good knowledge of the drug development process
  • Outstanding communication, organisational, and problem-solving skills
  • Demonstrated ability to deliver results to the appropriate quality and metrics
  • To be a self-starter, capable of working with minimal direction and seeking a role that fosters personal growth
  • The ability to establish and maintain effective working relationships with a diverse range of stakeholders

 Key Responsibilities

  • Responsible for leading and overseeing the project team for quality execution of assigned project(s) on time and within budget and in accordance with ICH-GCP, company SOPs, policies and applicable regulations.
  • Co-ordinate efforts of cross-functional project teams within and outside the company and third-party vendors (CROs, central labs, EDC, IP Logistics, etc.) to support milestone achievement and to manage study issues and obstacles.  
  • Develop and review project documents and project management plans 
  • Manage project budgets/finance and approval of invoices and tracking deliverables 
  • Review and approve CRA visit reports and key study project plans
  • Conduct regular quality control on study TMFs and perform quality visits at investigational sites.
  • May support the Head of Clinical Operations in staff professional development, and mentor team members on risk and issue resolutions for assigned projects/tasks. 
  • May perform Line Management responsibilities within clinical operations.

 Qualifications

  • A Bachelor’s degree in Life Sciences or a related field
  • A minimum of seven years of clinical research experience including 3 years project management experience
  • Good knowledge and monitoring experience in oncology studies

How to Apply

If you’re excited by the opportunity, have at least seven years of clinical research experience, including 3 years in project management roles, and possess the relevant qualifications, we’d encourage you to apply.  

Please submit your resume and a cover letter to: jo@amplificare.com.au.

Please only apply if you are a Sydney-based candidate with the right to work in Australia!