Job Information
ICON Strategic Solutions Scientific Leadership Research Coordinator - Oncology in Topeka, Kansas
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.
What will you be doing?
The Scientific Leadership Liason is responsible for the coordination of scientific engagements and Investigator Studies Program (MISP) activities in support of the Global Scientific Affairs team.
What do you need to have?
Assist with analysis of the content of each study application and check for completeness: budget, timelines, publication plan
Facilitate review of final study report and submit abstract/manuscript to committee and databases
You will be the primary point of contact to ensure the committee decisions are communicated and document according to SOP
Coordinate activities with the investigators and country point of contact to ensure approved studies are initiated, followed-through, and completed within the time frame agreed upon according to the executed study agreement
Ensure clinical studies have IRB/IEC approval and are registered on the CTDB.
Track and manage all documents via a global website and database for the Global Scientific Affairs team
Facilitate, review and negotiations of clinical and pre-clinical study designs, budgets, timelines, grant agreements.
Coordinate with the Global Operations Specialist regarding CDAs, study budgets, contracts, approval of payments to investigators/institutions, forecasting and budgetary spending.
Liaise with World Wide Regulatory Coordination to ensure appropriate documentation is obtained for clinical drug supply needs
Responsible for fostering relationships with internal and external partners to encourage study teams to move forward during difficult times of transition within the company
Managed and executed Scientific Input Engagements and Global Therapeutic Expert Forums (Investigator Meetings) for the Therapy area assigned in compliance with all US and International government regulations.
Supported the Global Scientific Affairs Team for the therapy area assigned and activities surrounding scientific leadership strategy which drove post-marketing and clinical research initiatives
Managed Investigator Initiated Studies Program from study initiation to study completion.
Managed Global Scientific Affairs budget and reported financial status monthly.
5+ years of clinical research experience required, including at least 2 years experience in clinical trial management
Read, write and speak fluent English; fluent in host country language required.
Will require strong Power Point and Excel experience and teh flexiblity to travel on occasion.
Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required.
Experience in managing all trial components (start-up to database lock) preferred
Experience in coaching/mentoring other CTMs, leading a team of CTMs, participating in departmental initiatives preferred
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.