Senior TMF Lead
About the role
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- As a Senior TMF Lead, 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
- 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
- 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.
- 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 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.
- Responsible for identifying and addressing the resourcing needs for the group in coordination with Manager/Sr. Manager. Participate in the selection and recruitment of suitable and qualified staff, as required.
- Conduct performance appraisals and assign responsibilities as appropriate for team.
- Support Senior Management in monitoring and minimizing costs.
- A Bachelor’s degree, or local equivalent, is preferred.
- Background in scientific disciplines desired
- Relevant TMF Operations experience. Knowledge offiling procedures and eTMF application is mandatory. Supervisory exposure, resource planning andstaff recruitment preferred.
- Excellent Verbal/written communication and interpersonal skills. Fluency in English.
- Well-developed influencing and negotiation skills with ability to interact with all levels in the organization
- Capability of managing competing priorities in a changeable environment and ability to handle deadlines
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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