Study Startup Specialist I (18-months contract)
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Job Location:
Monthly Salary:
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
Take your career to the next level and lead challenging study activation process in Australia. You will support clinical research teams and ensure PSI projects start smoothly and on time.
Were looking for a SSU Specialist I on a 18-month contract to support our increased workload. This is a great opportunity for someone looking to gain hands-on experience in clinical research.
You will:
- Maintains study-specific and corporate startup tracking systems
- Facilitates site budgets and contract negotiations
- Supports site regulatory document collection
- Under supervision may prepare initial and amendment submission dossiers to competent authorities ethics committees and/or site submission dossiers (as applicable)
- Communicates with the project team and investigational sites throughout the entire duration of the study
- Develops site specific startup timelines and enrollment projections and is responsible for meeting the site activation milestones
- May review study specific translations
- Supervises Trial Master File (TMF) maintenance throughout the study startup phase
Qualifications :
- At least 1 year industry experience in clinical research and/or a minimum 1 year of Study Startup experience in the Australia
- Bachelors degree or above preferred in pharmaceutical/healthcare related majors
- Excellent communication skills both written and verbal
- Full working proficiency in English
- Proficiency in MS Office (Word Excel PowerPoint Outlook)
Additional Information :
Culture And Benefits
We prioritize the well-being of our team and as part of our commitment we offer:
- A hybrid work arrangement with two flexible work-from-home days and three on-site days each week.
- Our office is located in Macquarie Park and we offer onsite parking for your convenience.
- Opportunities for learning and professional development.
- Access to mental wellness programs.
- Novated leasing options.
- The chance to work within a meaningful industry in a global organization setting.
How are we different
PSI is privately owned by the very people who founded the company more than 30 years ago and theyre still working here today. As a result we have grown organically around the globe and have kept our company fully independent giving us significant advantages and freedoms.
Growth Opportunities
PSI is proud to invest in our people from entry-level team members to senior leaders helping you identify and hone your unique strengths at every step of your career. From on-the-job learning experiences to formal development programs our professionals have a variety of opportunities to continue to grow throughout their career.
Remote Work :
No
Employment Type :
Full-time
Key Skills
- IVR
- SOAP
- Avaya
- Solaris
- Cost Accounting Standards
- Database Design
- Hibernate
- ITIL
- Weblogic
- Express.js
- Contracts
- ASP
About Company
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on on-time project delivery. This is achieved through investing substantial effo ... View more
