Clinical Study Associate Manager Posted Date 14 hours ago(1/23/2025 10:45 AM) ID 2025-116147 Location : Location US-Remote Overview
As a Clinical Study Associate Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities
What you will be doing:
May lead/oversee the planning and management of a clinical study in an assigned region(s) in alignment with the global study plans and may contribute to global planning and management of the studyContributes to risk assessment and helps identify risk mitigation strategiesSupports feasibility assessment to select relevant regions and countriesOversees and provides input to the development of study specific documentation including but not limited to: case report form (CRF), data management plan, monitoring plan, monitoring oversight plan, etc.Reviews site level informed consents and other patient-facing study start-up materialsOversees setting up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS) and Trial Master File (TMF) Contributes to investigator meeting preparation and executionOversees engagement, contracting and management of required vendors for the studyOversees and provides input to study drug and clinical supplies forecasting, drug accountability and drug reconciliationProvides regular status reports to stakeholders as requested by the Clinical Study LeadContributes to development of and oversees implementation of recruitment and retention strategiesMonitors recruitment and retentionMonitors progress for site activation and monitoring visitsSupports data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations and suspected non-compliance by sitesEscalates data flow and data quality issues to Clinical Study LeadOversees the execution of the specific clinical study deliverables against planned timelinesEscalates issues related to timelines or budget to Clinical Study LeadSupports accurate budget management and scope changesContributes to clinical project audit and inspection readiness throughout the study lifecycleSupports internal and external inspection activities and contributes to CAPAs as requiredManages aspects of study close-out activities including but not limited to database lock, reconciliation of vendor contract, study budget, TMF and study drug accountabilityMay be responsible for mentoring clinical trial management staffMay be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoringMay require up to 20% travelLocation Eastern timezone Qualifications
You are:
Bachelors Degree and 4+ years of relevant industry experience.Excellent communication and interpersonal skills; ability to build relationships internally and externallyA data driven approach to executing and problem solvingAttention to details for the ability to deliver on specific study activitiesTechnical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMFProactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritizationBudget awareness with the ability to participate in various aspects of budget managementFamiliarity with medical termsVendor management experienceExperience in clinical trial operations including experience developing key study documentsKnowledge of ICH/GCP and regulatory guidelines/directives
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlementsA range of health insurance offerings to suit you and your family’s needsCompetitive retirement planning offerings to maximise savings and plan with confidence for the years aheadGlobal Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-beingLife assuranceFlexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
https://careers.iconplc.com/reasonable-accommodations
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
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