Senior Project Manager Posted Date 12 hours ago(11/19/2024 11:46 AM) ID 2024-115017 Location : Location US-Remote Overview
As a Senior Project Manger you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities
What you will be doing:
Responsible for the implementation of RBQM procedures for assigned studiesReviews study protocol and facilitates development of the Study Risk Assessment that defines critical data, critical processes, including quality tolerance limits in collaboration with the study teamDevelops study specific content and leads RBQM training and RBQM kick-off meetiAuthors and implements the study specific RBQM planLeads risk assessment meetings, engaging cross-functional study team members to identify Critical-to-Quality (CtQ) risks throughout the trial lifecyclePartners with the RBQM system configuration team to ensure risk indicators, quality tolerance limits and other analytics/visualizations are programmed and functioning per operational requirements in the RBQM systemPerforms periodic central monitoring of the aggregate data at the study, region, country, site, and patient levels leveraging available analytics/visualizations in the RBQM system to identify emerging risks and/or issuesLeads risk review meetings and discussions with study team members to effectively communicate and discuss the findings, facilitates and encourages robust root cause identification and mitigation strategiesEnsures corrective actions and preventative actions are properly documented, assigned, and implemented by assigned study team members and/or impacted functionsMonitors the effectiveness of study risk mitigation actions in reducing the risk signals; makes recommendations to adjust as neededCreates signal and trending reports for study teams to support their interpretation of RBQM outputPartners with the Adaptive Monitoring Excellence team for signals requiring review or adjustment to study level plans for targeted source data verification and source data reviewMaintains up-to-date, accurate documentation of RBQM activitiesSupports and participates in internal and external audits and inspectionsMaintains high quality, consistency, and compliance with RBQM procedures across studiesAdjusts RBQM plan appropriately based on both anecdotal feedback and data-driven trends in overall RBQM success measuresIdentifies and shares best practices, successes, case studies, failures, and process improvement opportunities to promote continuous improvement and consistency with RBQM processesActs as a change agent, champion, subject matter expert and point of contact of RBQM methodology, leading study teams to understand and follow the best practices to achieve maximum benefitSupports inspections and regulatory interactions as it relates to Takeda’s adoption of RBQM frameworkMay perform line management of other (junior) staff within RBQM Operations
Qualifications
You are:
Minimum of 6 years of experience in the pharmaceutical or CRO industryMinimum of 2 years of experience in Risk Based Quality ManagementMinimum of 2 years managerial and supervisory experienceBachelor’s Degree in a health-related, life science area or international equivalent preferred, or equivalent combination of education, training, and work experienceRobust understanding of the drug development process and clinical trial execution Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP)Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive ActionsKnowledge of RBQM IT systems or other data analytic systemsDemonstrated ability to analyze data, identify patterns and make recommendations for improvement Demonstrated ability to effectively lead cross functional team meetingsExperience forming cross-functional collaborations; strong interpersonal skillsSupports a culture of continual improvement and innovation; promotes knowledge sharingAbility to influence without authorityThinks creatively; challenges the status quo
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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