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.
Description of Role & Responsibilities
The GCDS TA Lead is a subject matter expert in the area of data standards as it relates to developing clinical data collection tools. The individual may be responsible for coordinating data processes related to new therapeutic areas, which may require them to create standards from scratch rather than work to update or change existing standards. The GCDS TA Lead is able to work independently or as a team member or leader with equal effectiveness. The GCDS TA Lead interacts with staff across multiple Merck sites, and mentors, guides, and provides project leadership for junior staff as assigned. The GCDS TA Lead may participate in process design and/or implementation initiatives.
Minimum FTE Years of Experience
8+ years’ work experience, which includes 4 years of data management experience and a minimum 2 years in clinical data standards development; or advanced degree with 6+ years’ work experience of which 2 years need to be in clinical data standards development.
Advanced knowledge and leading-edge skills in clinical data standards.
Study Data Tabulation Model (SDTM) expertise
InForm expertise
Analysis & Reporting experience
Program-level clinical and business requirements knowledge
Communication/presentation skills
Education/training/facilitation skills
Must have an innovative spirit, outstanding interpersonal skills, leadership and demonstrated proficiency in the management of multiple projects. Knowledge of clinical data management.
Educational Requirements
B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline
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.