Senior Study Start Up Specialist (Office & Home Based, 3 to 4 years exp)

Next Day Consulting

Offering great flexibility and perks, this position would suit a Senior SSU with 3 to 5 years experience, packages in excess of $140,000 available.

Senior Study Start-Up Specialist

About the client:

An award-winning CRO that services both the pharmaceutical and biotechnology industries.  They are looking to hire a Senior Study Start-Up Specialist to join their Sydney team.  An office-based position offering the flexibility of 1 or 2’s day working from home. 

The chosen individual will have 3 to 4 years specific startup experience, an articulate and driven professional that can serve as the primary contact for Investigators and Research Professionals.  

You will:
  • Manage end to end study site level critical documentation
  • Perform feasibility assessments, site identification, and selection
  • Negotiate budgets and Clinical Trial Agreements
  • Prepare, review and approve study-related ethics / regulatory submission packages and more
  • Develop Country-specific information sheets and consent forms
  • Meeting attendance (i.e. kick-off, bid defenses)
  • Approx. 10% travel domestic and/or international
  • Data entry of SSU activities into the system
  • Assemble and distribute study material to project teams
  • Perform timely follow-ups of queries made by Ethics
  • Undertake and fulfill study start-up team leader activities
  • Provide country-specific Study Start-Up expertise to project teams
  • Support and perform according to ICH GCP and Australian guidelines and standards
Requirements to apply:
  • Tertiary Science degree
  • At least 3 years’ experience in Study Start-Up
  • Excellent knowledge of GCP/ICH, FDA, EMEA and local regulations
  • Australian clinical trial experience
  • Organised, friendly and enthusiastic
  What’s on offer:
  • Drive new trials
  • Friendly company culture and terrific team spirit
  • Flexible working hours either home or office-based
  • Excellent development program 
  • Base depending on experience up to $100,000
  • Plus a bonus, super and vehicle - $140,000 package 

If you would like to discuss the role further, please feel free to send your CV via this link and a Next Day Consultant will be in contact or for other opportunities check out 

Next Day Recruitment is a leading recruitment specialist in the Australian and Asia Pac market. We believe that the best way for you to predict your future is to help you create it. We offer a full range of permanent, contract and consultancy recruitment solutions to a number of Australia's and Asia Pac's leading Healthcare companies.