You will need to login before you can apply for a job.Sector: Research and Development, Science and PharmaceuticalRole: ManagerContract Type: PermanentHours: Full TimeAs a Lead TMF Specialist, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.The role independently maintains the Trial Master Files for assigned studies, participating in end-to-end TMF management activities, including adherence to organizational TMF standards and study-level quality control reviews, and facilitating issue resolution.What you will be doing:Ensure TMF completeness and accuracy based on client's SOPs and regulatory requirementsMaintain study-level TMFs including QC review, analysis, and vendor oversight (if applicable)Conduct content review of a variety of documents in a short time frame while maintaining consistency and attention to detailPrioritize work accordingly to meet departmental needs and work toward and meet deadlines with some supervisionGenerate metrics for department and study team usage supporting TMF completeness, timeliness, and qualityParticipate in inspection readiness reviews, preparation activity, and inspection conductProvide guidance and training as applicable to TMF stakeholders; serve as a resource to colleagues on more advanced TMF activitiesCoordinate onboarding of new staffParticipate in and may lead projects that require cross-functional collaboration or involve coordinating system updatesYou are:Bachelor's degree in relevant disciplineStrong verbal/written communication, presentation skills, and interpersonal skills to educate/train project teams and other stakeholders and exchange key informationEffectively communicates and coordinates activities within the group and other TMF stakeholdersMS Excel, Word, PowerPoint expertiseExperience working in a TMF platformExperience working in a CTMS platformPossess strong critical thinking skills with a focus on inspection readinessWhat 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.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.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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