Site Start-Up Specialist II: Regulatory Submissions

Premier Research

Poland

On-site

PLN 113,000 - 143,000

Full time

3 days ago

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Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Employee Assistance Program

Job summary

Premier Research is seeking a Site Start up Associate I/II to join the Clinical Monitoring, Site Management and SSU team in Poland. The role supports biotech, medtech, and pharma firms by preparing regulatory submissions and coordinating site contracts to enable timely trials.

The ideal candidate has substantial start-up experience, strong knowledge of CTIS submissions, and familiarity with FDA/EU guidelines.

Qualifications

Undergraduate degree in clinical, science, or health field.
5+ years of related clinical trials experience, including 3+ years in CTIS submissions.
Experience in contract and budget negotiation with sites.
Knowledge of FDA/EU regulations and ISO14155.

Responsibilities

Forecast submission/approval timelines and ensure adherence.
Prepare and submit EC/IRB, Local EC, RA, and other local submissions; assist with issue resolution.
Prepare ongoing submissions, amendments, and notifications including safety reporting.
Collect and review essential documents to ensure sponsor and investigator compliance with local regulations.
Negotiate site contracts and budgets; coordinate with Contracts Lead until resolution.
Conduct country-level site identification/feasibility assessments.
Prepare IP checklist according to country regulations.
Ensure TMF documents are accurate and QC’d for sites acting as document owner.