ICON Clinical Research TMF Supervisor (Group Lead) in North Wales, Pennsylvania

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.

Our Trial Master File Group Lead plays a key role in ensuring the completeness and accuracy of the Trial Master Files (TMFs). This is accomplished by providing line management, leadership support to the TMF Specialist teams along with process and project management. The TMF Group Lead will ensure team deliverables are with expected quality and timelines. Act as a mentor to TMF Leads and Specialists under the guidance of a Sr. Manager of TMF Operations.

  • Overview of the Role*

  • 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

  • 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.

  • Role Requirements*

  • A Bachelor’s degree, or local equivalent, is preferred.

  • Background in scientific disciplines desired

  • Relevant TMF Operations experience with a minimum work experience of 7+ years. Knowledge of filing procedures and eTMF application is mandatory. Supervisory exposure, resource planning and staff 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

  • Benefits of Working in ICON*

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. Your dedicated recruiter will discuss this information with you during your phone interview.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

  • What’s Next?*

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

  • ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.*