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:
Line Management:
•As a Group Lead/Line Manager, the employee is expected to recognize the importance of and create a culture of process improvement with maximum focus on streamlining our processes adding value to our business and meeting client needs
•Travel (minimum 5%) domestic and/or international as and when appropriate
•Effectively manage resourcing of central filing staff to ensure TMF Specialist activities are performed as per established process, timeframes and quality standards and that targets are met to the Operations team and sponsor’s satisfaction.
•Line management and leadership of team including, setting appropriate goals and objectives; offering assistance and mentoring to team members wherever appropriate to create a supportive working environment; developing effective working relationships with the team engendering an atmosphere of motivation, creativity and innovation whilst providing opportunities for learning and development within the team.
•Recognize, exemplify and adhere to ICON's values, which centre on our commitment to People, Clients and Performance.
•As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs.
•Support and Mentor Lead TMF Specialists and extend technical support on an ongoing basis
•Ensure TMF Specialist teams achieve productivity and quality targets, perform benchmarking reviews and perform oversight of deliverables using different tools/techniques and maintain and report relevant metrics
•Work with TMF Specialist groups/teams to determine the best method of resolving indexing and filing errors or inconsistencies and provide regular performance feedback to team. Capture user feedback on central filing activities. Participate in the modification of systems, process and training as required by pilot results.
•Represent TMF Operations during internal/external/sponsor audits and manage findings through effective resolution both operationally and within the Quality Management System
•Manage the performance of the TMF Specialists group vis-à-vis established timeliness, budget, quality standards and/or contractual requirements during the pilot phase and post pilot phase.
•Keep senior management informed of any human resource related issues within the organisation which require attention.
•Monitor employee absences and continue to ensure absenteeism is kept within acceptable limits.
• Represent the TMF Operations group within business. Attend and contribute to management meetings as required.
Process/Project Management:
•Act as Subject Matter Expert for all the TMF Specialist activities in TMF operations
•Support project management of activities supported in all locations, liaise with project/study teams, functional groups/clients and escalate issues to local/senior management and global study teams in a timely manner
•To competently 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 TMF Operations staff in order to fulfil 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 maintain study files as per study and/or client requirements or in accordance with ICON SOPs/WPs and applicable regulations.
•*To provide information necessary to complete client and/or departmental status reports as requested by the management of the TMF Operations department.
• *To inform the Manager of training issues, project activities, quality issues and timelines as directed.
Requirement:
Minimum 4-5yrs of experience as TMF lead
Experience in client interactions, set up and close out of TMF
People management experience is an added advantage
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.
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