Clinical Study Lead
Company: ICON Strategic Solutions
Location: Baton Rouge
Posted on: January 27, 2023
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.The Clinical Trial
Manager II (CTM II) will provide trial operational oversight of
CROs and vendors (including both U.S. and Ex-U.S. regions). This
role also assures adherence to GCP, regulations and applicable
procedures, in addition to protocol compliance and that of study
related plans.Job Duties:
- Vendor (e.g., CRO, Biometrics, IXRS, PK/Central Lab, eTMF,
Safety) oversight for adherence to budget, timelines and
organizational objectives of individual protocols/programs.
- Develops strong vendor and site relationships and ensures
continuity of relationships through all phases of the trial.
- Obtains and maintains in-depth understanding of the study
protocol and related procedures in order to contribute strongly to
study team knowledge by sharing best practices, making
recommendations for continuous improvement and providing training
- Coordinates & manages various tasks in collaboration with other
sponsor roles to achieve site readiness, such as study materials
and approval for drug shipping/receipt according to procedure.
- Performs timely review of monitoring reports from CRO and
associated deliverables demonstrating sponsor oversight.
- Perform periodic reviews of the CRO eTMF/TMF to ensure
adherence with standards and compliance with the relevant
regulations and guidelines.
- Works with vendors to revise scope of service agreements,
budgets, plans and detailed timelines, and ensure that performance
expectations are met.
- Supports financial management of the study which includes
review and approval of site and vendor invoices.
- Supports risk Management initiatives
- Supports audit/inspection activities as needed.
- Maintain clinical trial registry entry/updates, as
- Provides mentorship/guidance to junior team members or
cross-functional colleagues on study processes/study
- Undergraduate degree or its international equivalent preferably
in clinical, science, or health related field from an accredited
institution; a licensed health-care professional, i.e., registered
- 5 years of relevant experience
- Minimum 3 years of experience in clinical research, including a
management role as a team lead or project manager experience.
- Reads, writes and speaks fluent English; fluent in language of
host country.Benefits of Working in ICON:Our success depends on the
knowledge, capabilities and quality of our people. Thats 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.
Keywords: ICON Strategic Solutions, Baton Rouge , Clinical Study Lead, Healthcare , Baton Rouge, Louisiana
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