Regional Clinical Trial Mgr
Job ID: R-35564
Australia - Field/Remote Nationwide
Australia – Field/Remote
Posted Date: March 13, 2017
Regional Clinical Trial Manager (RCTM)
Based in Sydney or Melbourne
If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As part of the Global Clinical Program Management (GCPM) function, the core focus of the RCTM is to lead and manage the conduct of clinical trials from study start-up to closeout across multiple countries in accordance with ICH-GCP and applicable local regulations. Key will be the collaboration with other RCTMs and the Global Clinical Trial Manager (GCTM) for global execution of studies. In addition, the RCTM will collaborate with cross functional internal and external stakeholders to ensure timely and on budget execution of clinical trial deliverables within the region.
Providing regional input into operational planning activities
Management and reporting of clinical studies in region conducted by Global Development through oversight of study activities, identification and resolution of issues, and communication of study timelines/deliverables to GCTM
Ensuring implementation of study(ies) in accordance with SOPs and ICH/GCP guidelines
Management of study budget and timelines
Management of vendors to the required standards (may include vendor set up and oversight through the course of the study)
Qualifications, Skills, Knowledge and Experience:
Bachelor’s degree ( or higher qualification) & 5 years of directly related experience
Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.)
Advanced knowledge of clinical trial management including regulations and guidelines across multiple countries
Clinical trial processes and operations
Extensive knowledge of ICH/GCP regulations and guidelines
Project and Program management including oversight of study deliverable, budgets and timelines
Key performance indicators (KPIs)
To be considered for this excellent opportunity, apply now.