Senior eTMF Specialist

Title - Senior eTMF Specialist

Location - UK, homebased

Sponsor dedicated

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Senior eTMF Specialist is the subject area expert of both eTMF and TMF. They'll be a member of internal center of excellence to maintain our clients process and knowledge, and manages the outsourcing vendor to perform according to the service level agreement and our clients business requirements.

In this role you will be responsible for the following tasks:

• Write processes to describe system functionality. 
• Supports the study teams regarding initial eTMF activities, for example, set-up of study specific TMF Plan for any given study
• Oversees the vendor activities and addresses issues with vendor
• Provides eTMF process guidance and inputs for improvements
• Interprets the TMF business rules into technical system requirements
• Contributes to or leads or supports eTMF enhancement projects
• Provides mentorship and training to new and less experienced staff
• Monitors, plans and coordinates eTMF process improvement implementation
• Responsible for change control and validation activities
• Development of best practices documents, user guides and internal training materials
• Supports GCDO Q&C activities to develop and monitor the eTMF quality metrics
• Performs project management and process governance activities when delegated by eTMF Global Lead
• Participates in eTMF audits and inspections
• Subject matter expert for QSD creation and update

To be successful in this role, you'll need to have the following:

• Senior TMF management expertise and experience in Veeva Vault Clinical
• Knowledge regarding TMF metrics and QC activities of EU CTR submission documents would be preferable but not mandatory
• Bachelor degree plus 5 years’ experience in Clinical Development coupled with 2 years required experience with TMF, or Associates degree plus 7 years' experience in Clinical Development coupled with 2 years required experience with TMF or High School Diploma plus 9 years' experience in Clinical Development coupled with 2 years required experience with TMF.
• Strong English and communication skills, both written and verbal
• Must have an advanced level of knowledge of all relevant industry guidance and standards (eg. FDA, EMA, ICH, DIA) as they relate to the creation, exchange and lifecycle management of Trial Master Files.

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.