Senior TMF Specialist

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 TMF Specialist will be responsible for the high quality of clinical study documents from study start through to final archival, ensuring compliance with company SOPs and process.  A focus on inspection readiness is critical.

The key duties and responsibilities associated with this position include but are not limited to the following:

Primary Responsibilities / Activities:

• Independent review, and approval of study, country, & site level documents within agreed timelines and in accordance with ICH, GCP, and all applicable regulations, laws and other guidelines.
• Monitor overall completeness and quality of the Trial Master File (TMF) (start up to archival), and provides status updates to study teams
• including elements outsourced to CRO
• Support study teams to ensure inspection readiness of clinical trials
• Work with study team to establish TMF plan & strategy
• Oversees consolidation and archive preparation of the clinical TMF, liaising with CRO partners to ensure compliance with company SOPs and timelines throughout process
• Internal Archive Prep
• Ensures continuous improvement of processes and quality of documents
• Provides TMF status updates to trial and cross-functional teams as required
• Manage TMF requests that come through the Incyte Service Help Desk
• Assist with User Acceptance Testing (UAT) of eTMF updates
• Random checks for TMF Health

Qualifications:

• Minimum 3 years of experience in the pharmaceutical industry related to management of clinical documents
• Familiarity with ICH/GCP and overall understanding of regulatory guidelines
• Strong organization and time management skills
• Flexibility to assume a workload which frequently necessitates an adjustment of priorities
• Goal oriented self-starter with ability to proactively identify issues
• Motivated to work in a fast-paced, challenging environment 
• Firm understanding and sense of the importance of paying attention to detail
• Independent & Team setting

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.