Ref #: 33764

Employment type: Permanent - Full-Time

Location: US- Northeast


Our client is looking for TMF specialists who are interested in a remote opportunity. You will be dedicated to one sponsor supporting many therapeutic areas.

About the job:

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.

What will you be doing?

• Contribute to the preparation of training materials (Investigator Meetings, Site Evaluation and Initiation Training)
• Manage process for planning and procuring ancillary clinical supplies
• Facilitate and collate country recruitment plans
• Create and manage study specific tools such as recruitment and retention materials and study newsletters
• Maintain study level storyboard
• Facilitate authoring of Investigational Product Information Manual (IPIM) and study specific Important Protocol Deviation (IPD) list
• Compile IRB/EC submission documentation
• Assist with Global Development Operations (GDO) Operational Review preparation
• Prepare Clinical Study Team (CST) meeting agendas and minutes
• Manage global versioning and distribution of informed consent forms (ICFs)
• Facilitate cross functional meetings
• Submit documents to trial master file (TMF)

What You Need to Have:

• eTMF experience
• Understanding of drug development process
• Familiar with advanced concepts of clinical research
• Advanced computer skills
• Detailed knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
• Ability to write and present clearly using scientific and clinical issues terminology
• Experience dealing with time demands, incomplete information or unexpected events
• Good organizational and planning skills
• Experience working effectively in a team/matrix environment

Benefits of Working in ICON:

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.

At 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.

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, color, 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.