Senior Clinical Study Lead Posted Date 18 hours ago(1/29/2025 9:59 AM) ID 2025-116653 Location : Location US-Remote Overview
As a Senior Clinical Study Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities
What you will be doing:
Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned studyProvides operational input into protocol developmentOversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.Ensures compliance with the clinical trial registry requirementsIdentifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendorsProvides input into baseline budget development and managementProvides input into baseline timeline development and managementLeads risk assessment and identifies risk mitigation strategies at the study levelLeads the feasibility assessment to select relevant regions and countries for the studyOversees/conducts site evaluation and selectionLeads investigator meeting preparation and executionMonitors progress for site activation and monitoring visits and acts on any deviations from planLeads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from planMonitors data entry and query resolution and acts on any deviations from agreed metrics • Ensures accurate budget management and scope changes for internal and external studiesOversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliationEscalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issuesOversees the execution of the clinical study against planned timelines, deliverables and budgetOversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sitesOversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of workEnsure clinical project audit and inspection readiness through the study lifecycle• Supports internal audit and external inspection activities and contributes to CAPAs as requiredManages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountabilityContributes to clinical study report writing and reviewFacilitates and contributes to study level lessons learnedAssigns tasks to Clinical Study Management staff and supports their deliverablesRecommends and participates in cross-functional and departmental process improvement initiativesResponsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPsMay 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 monitoring Qualifications
You are:
Undergraduate degree or its international equivalent preferably in clinical, science, or health related field from an accredited institution; a licensed health-care professional, i.e., registered nurse8 years relevant study management experience Demonstrated interpersonal & leadership skillsAbility to understand and implement the strategic direction and guidance for respective clinical studiesA data driven approach to planning, executing, and problem solvingEffective communication skills via verbal, written and presentation abilitiesProactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritizationAbility to influence and negotiateBudget management experienceAn awareness of relevant industry trendsAbility to build productive teams and collaborationsDemonstrated vendor management experienceTechnical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDCExperience in global clinical trial operations including experience developing protocols and key study documentsKnowledge of ICH/GCP and regulatory guidelines/directivesEffective project management skills, cross-functional team leadership and organizational skillsExperience in rare disease preferredUp to 25% Travel (as needed)
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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