.At ICON, it's our people that set us apart.
Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity.
We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point.
In short, to be the partner of choice in drug development.That's our vision.
We're driven by it.
And we need talented people who share it.If you're as driven as we are, join us.
You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.ICON plc is a world-leading healthcare intelligence and clinical research organization.
From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.With our patients at the center 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.
**As TMF Lead you will**:- Own the TMF deliverable- Engage and lead cross-functional teams to achieve Inspection Ready eTMFs at all times- Deliver best-in-class customer support for our Sponsors/Clients whether using our ICON eTMF or an external eTMF.- Actively listen to and deliver insightful solutions for challenges- Identify opportunities to create efficiencies and participate in automations & integrations- Lead the setup of the TMF- Monitor and drive completeness and quality of TMF content for all assigned clinical trials until study close out.- Oversee documentation flow within projected timelines and determine course of actions to prevent and remediate delays and errors.- Ensure consistent use of standardized processes and systems across assigned clinical trials and programs- Assist with the development and implementation of the TMF specifications, such as process and system changes.- Serve as primary point of contact for internal and external audits of study TMF-related queries and support the preparation of appropriate audit and inspection responses.- Facilitate communication and interaction among study team members from the set up until the closing of the TMF for a clinical trial.- Provide education, feedback and support to Study Teams in order to build knowledge and awareness of good document management practices and TMF for clinical trials