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Start up Specialist


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Assisting Project Management with planning and logistics of site start up activities;
Together with the PM, to set up sites and drive the site start up process including direct point of contact for site team during start up phase;
Responsible for all site start up activities from feasibility to site activation including but not limited to HREC, TGA submissions and approvals, contract and budget negotiations, ICF development, generation and collection of essential documents;
Support trial sites in meeting timelines and proactively inform the PM and project team of local requirements and updates.


Tertiary qualifications in clinical or life sciences related field (relevant experience/qualifications in similar professions may also be considered);
Solid knowledge of GCP, basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations;
Minimum 2-3 years of experience in SSU;
Familiar with the current HREC and RA requirements, including review and approval, processes, and document requirements for submissions;
Experience assisting clinical sites with IRB/IEC and local institution submissions;
Strong attention to detail and quality of documentation;
Effective oral and written communication skills;
Excellent interpersonal and team skills with a genuine commitment to contributing to the development of innovative treatments.