Senior TMF Specialist - ICON Full-time Job

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives. Our ‘Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That's our vision. We're driven by it. And we need talented people who share it. If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry. Job Description :To process study documents in accordance with client and study requirements as per study-specific processes, ICON SOPs/WPs and regulations, where applicable.To liaise with study teams and other Document Management staff in order to fulfill job responsibilities and activities and to assist in providing guidance to study teams for study file archiving activities.To complete departmental projects as assigned in accordance with specified timelines, ICON SOPs/WPs and regulations.To evaluate business processes and procedures for effectiveness and efficiency and to make recommendations to the Manager for improvements.To develop and implement new business processes as directed by the Manager.To maintain document record and filing supplies ensuring adequate supplies are available to Document Management staff.To act as a project lead in Document Management, assisting the Manager with coordinating document management activities in fulfillment of ICON business needs and/or client services contracts. This would include but is not limited to: Coordinating Document Management staff activities on the projectGenerating status reports for ICON and clientsTraining and mentoring staffLiaising with Corporate Training and Development to ensure training is completed in compliance with ICON and/or client requirements and assisting with curriculum development where necessaryDeveloping study-specific proceduresTo manage and maintain document files and storage areas in accordance with ICON and/or client requirements and SOPs/WPS and applicable regulations as directed by the Manager.To complete, document and track activities related to document receipt and processing which may include but is not limited to: document receipt and review, scanning and indexing, quality control, copying, filing, forwarding or return to client/study teams and archiving.To develop, compile and submit client and/or departmental status reports as requested by the management of the Document Management department.To inform the Manager of training issues, project activities, quality issues and timelines as directed.To provide copies of study documents to ICON or client personnel as requested.To participate in client and/or ICON audits as necessary.To participate in document archiving activities as necessary.To participate in training related to fulfillment of responsibilities as required by ICON and/or the client.To liaise with Clients, as appropriate, on project issues when directed by the Manager. To handle special projects or duties as requested by the Manager. Requirements:Overall 5+ years of experience 4 years of relevant experience in TMF Minimum 1 year of experience in Period Review or TMF Review Benefits of Working in ICON:Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. ICON is an equal opportunity and inclusive employer and 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.