Senior Site Start-Up Lead, Clinical Trials

Premier Research International; Australia; On-site; AUD 100,000 - 150,000; Full time

Job summary

Premier Research International is hiring a Sr/Site Start up Associate II in Australia. You will lead country-level start-up activities, coordinating regulatory submissions, site contracts, and budgets to ensure compliant and timely study initiation.

The role requires knowledge of ICH/GCP and local regulations, with experience in submitting clinical trial applications and strong collaboration with Project Managers and Regulatory teams.

Qualifications

• Undergrad degree or international equivalent in clinical, science, or health field.
• Experience as SSUA I or at least 2 years in submission of clinical trial applications.
• Knowledge of FDA/EU regulations, ICH/GCP guidelines, and local regulatory requirements.
• Current working rights for Australia.

Responsibilities

• Take responsibility for country-level quality deliverables for study start-up and ensure compliance with country rules.
• Forecast submission timelines and provide rationale, contingency planning, and escalation as needed.
• Prepare and submit EC/IRB, RA, and local authority submissions and assist with issue resolution.
• Maintain essential regulatory documents and ensure sponsor/investigator requirements are met.
• Negotiate country-specific contracts and budgets with sites and Contracts Lead until execution.
• Provide country-level regulatory intelligence and liaison for site start-up and management issues.

Education

Undergraduate degree or international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional

Clinical start-up knowledge

Regulatory submission experience

ICH/GCP familiarity

Australian working rights

Job description

Premier Research International is hiring a Sr/Site Start up Associate II in Australia. You will lead country-level start-up activities, coordinating regulatory submissions, site contracts, and budgets to ensure compliant and timely study initiation.

The role requires knowledge of ICH/GCP and local regulations, with experience in submitting clinical trial applications and strong collaboration with Project Managers and Regulatory teams.