TMF Specialist II

To become familiar with Trail Master file documentation and TMF Operations activities in support of client services contracts and internal ICON business needs in accordance with client requirements and ICON procedures, as applicable

What you will be doing:

• Recognize, exemplify and adhere to ICON's values which centers around 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.
  
  • To acquire knowledge and skills to process study documents in accordance with client and study requirements as per study-specific processes, ICON SOPs/WPs and regulations, where applicable.
  • To acquire knowledge and skills to 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.
  • To liaise with study teams and other TMF Operations staff in order to fulfil job responsibilities and activities with supervision.
  • 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.
  • 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 fulfilment 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.
  • To provide inputs for improvement in the process of acquiring the knowledge and skills.

You are:

• Bachelor’s Degree or equivalent with 5+ years of experience in a pharmaceutical / biotechnology / CRO organization’s TMF / records management function.
• Experience in TMF management, knowledge of the TMF Reference Model, ALCOA+ standard, Good Documentation Practices, or relevant working experience in pharmaceutical/scientific environments.
• Veeva eTMF.
• General knowledge of clinical trials and basic principles of overall trial planning and execution.
• Basic understanding of ICH-GCP guidelines and FDA/EMA/PMDA regulations.
• Experience with  , MS SharePoint, MS Visio, Adobe Acrobat Professional, MS Excel, and MS PowerPoint, MS Word

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, 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, colour, 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.

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.