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Clinical Study Lead

Company: ICON Strategic Solutions
Location: Baton Rouge
Posted on: January 27, 2023

Job Description:

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 as appropriate/required.
  • 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 required.
  • Provides mentorship/guidance to junior team members or cross-functional colleagues on study processes/study requirements.Qualifications Needed:
    • 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 nurse
    • 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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