15 Sep
|
ICON Strategic Solutions
|
Montreal
15 Sep
ICON Strategic Solutions
Montreal
At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative setting where your work contributes to the development of treatments that benefit patients worldwide.
Trial and site administration: Update clinical trial databases (CTMS) and trackers Collate, distribute/ship, and archive clinical documents Assist with eTMF reconciliation Execute eTMF Quality Control Plan Regulatory & Site Start-Up responsibilities: In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions Support preparation of submission package for IRB/ERC and support regulatory agencies submissions. Publish study results for GCTO and RA where required per local legislation Develop country and site budgets (including Split site budget) Contract development, negotiation, approval and maintenance (e.g. Update and maintain contract; templates (in cooperation with Legal Department) Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable) Life Science preferred)
or equivalent healthcare experience Minimum 1-2 years in Clinical Research or relevant healthcare experience Fluent in Local Languages and business proficient in English (verbal and written} and excellent communication skills Must be bilingual in French Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications; Strong MS Excel skills required. Effective communication with external customers (e.g. sites and investigators) Demonstrates commitment to Customer focus. Must be able to go on site to sponsor office 2 days a week in Kirkland Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Competitive base salary and performance related incentives Health and wellbeing programmes including medical, dental, and vision coverage where applicable Retirement and pension plans Life assurance and disability coverage Employee assistance programmes and wellbeing resources Learning and development opportunities through structured training and career pathways Inclusion and Accessibility We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. #
📌 Bilingual Clinical Trial Coordinator - Regulatory- Montreal
🏢 ICON Strategic Solutions
📍 Montreal