Sr TMF Specialist

At ICON, it's our people that set us apart.

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 Senior TMF Specialist, you will handle eTMF 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 do

• Competently process study documents in accordance with client and study requirements as per study-specific processes, ICON SOPs/WPs and regulations, where applicable

• Act as a project lead in Document Management, assisting the Manager with coordinating document management activities in fulfilment of ICON business needs and/or client services contracts

• Complete activities related to document receipt and processing which may include but is not limited to:

• Coordinating Document Management staff activities on the project

• Generating status reports for ICON and clients

• Training and mentoring staff

• Liaising with Corporate Training and Development to ensure training is completed in compliance with ICON and/or client requirements and assisting with curriculum development where necessary

• Developing study-specific procedures

• Maintain study files as per study and/or client requirements or in accordance with ICON SOPs/WPs and applicable regulations

• Manage and maintain document files and storage areas in accordance with ICON and/or client requirements and SOPs/WPS and applicable regulations as directed by the Manager.

• Develop, compile and submit client and/or departmental status reports as requested by the management of the TMF Operations department

• Provide copies of study documents to ICON or client personnel as requested

• Complete departmental projects as assigned in accordance with specified timelines, ICON SOPs/WPs and regulations

What you need

• Bachelor's degree preferably in life sciences

• Must have 5 to 10 years in eTMF (Trial Master File) operations with strong knowledge of Clinical Studies documents

• Excellent communication skills

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.