Ref #: 30691

Employment type: Permanent - Full-Time

Location: Remote

Posted: 16-Jul-2021



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.

As part of The Managed Access team within Global Development (GD) Medical Affairs Operations (MAO) of our Global Strategic Solutions sponsor program, you will work with the team to ensure the operational planning, management and execution of all Managed Access initiatives globally including Pre-Approval Access and Post-Trial Access programs. By flawlessly managing Managed Access requests and providing access to investigational treatment that are not yet approved for use by health authorities we give new hope to people in need.

Job Description:
Reporting to the MAO GD Program Leader (GPL), the MAO GTL is accountable for end-to-end operational management of data generation activities or managed access requests.

This includes start-up, execution, close-out, analysis and reporting according to planned timelines and budget, and with high quality standards per company procedures and regulatory requirements.

The MAO GTL serves as the single point of end-to-end accountability for assigned programs leading the program teams on a global, regional level or local level, while partnering with the GD Program Leader (GPL), GD Operations Head (GOH), Global Trial Leader-Clinical Trial Assistant (GTM-CTA) to ensure overall program delivery at the global, regional and country level.

•Master's or Bachelor’s preferably in Life Sciences (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
•Minimum of 8 years of clinical research experience in the pharmaceutical industry or CRO. Other relevant experiences and skills may be considered.
•Specific therapeutic area experience may be required depending on the position.
•Project management skills and proficient communication skills are required.
•Ability to work in a virtual and highly matrixed environment.
•Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific proc
•Excellent decision-making and strong financial management skills.
•Leadership skills and ability to influence without authority.
•Be an agent of change management.
•Strong IT skills in appropriate software and company systems.
•Willingness to travel with occasional overnight stay(s) according to business needs
•Proficient in speaking and writing the country language and English. Good written and oral communication skills as appropriate.
•Willingness to travel with occasional overnight stay(s) according to business needs

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 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 through the form below.