Address
Form of work Growing global CRO is looking for an experienced SSU professional to join their team in Australia
Your new company
An opportunity has come available to join a growing, global CRO who are building out their team in Australia. You will join a team of experienced clinical research professionals along with a highly motivated and supportive leadership team.
Your new role
Reporting into the Global SSU Director, you will be part of a close-nit team in Australia, being responsible for coordinating study start up activities for Australian sites, and coaching and mentoring other members of the team as appropriate. You will be working on a range of studies across different therapy areas including oncology and dermatology. Location: home based position (this role is based anywhere in Australia)
Key responsibilities:
Driving early and predictable approvals through oversight of all activities, driving delivery and compliance in Australia
Minimising all potential causes of delay and managing compliance and reporting progress.
Providing support to the SSU country head with pre-award study/site feasibility
Providing support to the study team with import/export requirement of clinical trial supplies.
Providing assistance to other subsidiaries, departments or project teams with any country specifics issues if necessary.
Work with Project Director, Project Manager, Site Manager and Clinical Research Associates in the management of investigational sites to ensure compliance with study timelines, trial protocol, ICH/GCP and applicable regulations.
Respond to relevant inquiries on time.
Maintaining up-to-date status reports on all study start up activities and updating sponsors.
Participating in process optimization (including SOP review and daily workflow).
What you'll need to succeed
Full working rights in Australia
Experience in all aspects of SSU in a commercial clinical trial setting
Experience in both patient studies and healthy volunteer studies
Knowledge and understanding of local regulatory requirements and ICH/GCP guidelines
Bilingual in English and Mandarin is preferred but not essential
Ability to work independently and meet deadlines
What you'll get in return
The opportunity to join a growing, global CRO
Highly experienced leadership team
Strong team-work environment
Home based position
Competitive salary package
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV to maria.martinezdaza@hays.com.au, or call us now on (0)2 8860 1601 (Maria Martinez) to find out more. If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.
LHS 297508 #2760840
