Tmf Specialist

TMF Specialist - India Chennai Hybrid Office-based ICON plc is a world-leading healthcare intelligence and clinical research organization We re proud to foster an inclusive environment driving innovation and excellence and we welcome you to join us on our mission to shape the future of clinical development 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 This is an exciting opportunity to work within a fast paced busy environment for a leading global provider of outsourced development services to the pharmaceutical biotechnology and medical device industries As a TMF Specialist you will complete Document Management activities in support of client services contracts and internal ICON business needs What you do Process study documents in accordance with client and study requirements as per study-specific processes ICON SOPs WPs and regulations where applicable Liaise with study teams and other TMF staff in order to fulfill job responsibilities and activities Complete departmental projects as assigned in accordance with specified timelines ICON SOPs WPs and regulations Maintain study files as per study and or client requirements or in accordance with ICON SOPs WPs and applicable regulations Complete 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 Provide information necessary to complete client and or departmental status reports as requested by the management of TMF department Inform the Manager of training issues project activities quality issues and timelines as directed Provide copies of study documents to ICON or client personnel as requested Participate in client and or ICON audits and document archiving activities as necessary Participate in training related to fulfillment of responsibilities as required by ICON and or the client Liaise with Clients as appropriate on project issues when directed by the Manager Handle special projects or duties as requested by the Manager What you need Must have 1-15 years of TMF Trial Master File experience and strong knowledge of Clinical Studies documents Ability to successfully liaise with study project teams staff clients and management as necessary Good oral and written communication skills and interpersonal skills Bachelors Degree in Life Science preferred Why join us Ongoing development is vital to us and as a member of our team you will have the opportunity to progress your career with the potential to move into other related areas to enhance your skill set We offer a very competitive salary and benefits package that includes an excellent recruitment plan health coverage paid time off income protection insurance programs and staff recognition schemes 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 LI-AA1 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 entitlements A range of health insurance offerings to suit you and your family s needs Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead Global 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-being Life assurance Flexible country-specific optional benefits including childcare vouchers bike purchase schemes discounted gym memberships subsidised travel passes health assessments among others Visit our to read more about the benefits ICON offers At ICON inclusion belonging are fundamental to our culture and values 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 or submit a request 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 Are you a current ICON Employee Please click to apply