14 Aug
|
ICON Strategic Solutions
|
Winnipeg
14 Aug
ICON Strategic Solutions
Winnipeg
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 environment where your work contributes to the development of treatments that benefit patients worldwide.What you will be doing:Trial and site administration:Tracking (e.G. essential documents) and reporting [e.G, Safety Reports)Ensure collation and distribution of study tools and documentsUpdate clinical trial databases (CTMS) and trackersClinical supply & non-clinical supply management, in Collaboration with other country rolesManage Labeling requirements and coordinate/sign translation change requestDocument management:Prepare documents and correspondenceCollate, distribute/ship, and archive clinical documentsAssist with eTMF reconciliationUpdating manuals/documents (e.G., patient diaries, instructions)Document proper destruction of clinical supplies.Prepare Investigator trial file bindersExecute eTMF Quality Control PlanObtain translations of documentsRegulatory & Site Start-Up responsibilities:In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissionsObtain, track and update study insurance certificatesSupport preparation of submission package for IRB/ERC and support regulatory agencies submissions.Publish study results for GCTO and RA where required per local legislationBudgeting, Agreement and Payments: Collaborate with finance/budgeting representatives forDevelop country and site budgets (including Split site budget)Tracking,
and reporting of negotiationsMaintenance of tracking toolsContract development, negotiation, approval and maintenance (e.G. CTRAs)Update and maintain contract; templates (in cooperation with Legal Department)Payment calculation and execution (investigators, vendors, grants)Ensure compliance with financial proceduresMonitor and track adherence and disclosures,Budget closeout.Meeting Planning:Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)What you need to have:B.A./B.S. (Life Science preferred) or equivalent healthcare experienceMinimum 1-2 years in Clinical Research or relevant healthcare experienceMust have at least 2 years of budget negotiation experience.Fluent in Local Languages and business proficient in English (verbal and written} and excellent communication skillsMust be bilingual in FrenchGood understanding of Global; Country/Regional Clinical Research Guidelines and ability to work within these guidelines.Hands on knowledge of Good Documentation PracticesGood 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.ICH-GCP Knowledge appropriate to roleEffective time management, organizational and interpersonal skills,
conflict managementEffective communication with external customers (e.G. sites and investigators)High sense of accountability/ urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environmentWorks effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.Demonstrates commitment to Customer focus.Able to work independentlyProactive attitude to solving problems/ proposing solutionMust be able to go on site to sponsor office 2 days a week in KirklandEligible to work in Canada without visa sponsorshipEmployment 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.Perks may include:Competitive base salary and performance related incentivesHealth and wellbeing programmes including medical, dental, and vision coverage where applicableRetirement and pension plansLife assurance and disability coverageEmployee assistance programmes and wellbeing resourcesLearning and development opportunities through structured training and career pathwaysBenefits may vary depending on role and location.Inclusion and AccessibilityICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.#J-18808-Ljbffr
📌 Bilingual Clinical Trial Coordinator - Finance - Montreal (Winnipeg)
🏢 ICON Strategic Solutions
📍 Winnipeg