Clinical Study Manager - Early Phase - Lenexa, KS

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.

Qualifications

Qualifications:
  • Read, write and speak English; fluent in host country language required.
  • 1-3 years' experience in a field where organizational duties were a major part of duties;
  • Past leadership/management experience required;
  • Bachelor's degree required from a U.S. accredited educational institution or international equivalent.
  • Degree in science or healthcare related field preferred
  • Knowledge of CRO, Phase I Clinical Trials or related equivalent experience
  • Proven track record of excellent communication, time management skills, and customer service
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.

Responsibilities

Overview Refines or develops knowledge of Phase I GCP, ICH and other pertinent abilities through job to SOP training/orientation as assigned by functional manager. Prior to study commencement
  • Performs duties as a Clinical Study Manager including reviewing protocol and budget (works with accounting); working with Project Manager to organize operational aspects of study in the clinic including setting up source documents; serving as a liaison with Clinic Manager and staff; educating subjects about study operations; house rules; setting up needed outside vendors (additional studies required by protocol, eg Chest X-rays, echocardiograms, dental evaluations);
  • Sets up and hosts the SIV, working with PI/sponsor on dates, informing staff, acquiring room, making arrangements etc.
  • Prepares study-specific SSDL at the time study submission is made to IRB; makes available for staff who have completed on-line (Learning Links) study-specific Scientific Review (must present certificate of completion in order to be able to sign SSDL); makes available for attendees at SIV to sign and then transfers custody to CPCA personnel for keeping after SIV;
  • Responsible for distributing demographic list of subjects to be admitted for study; working with medical team members to create ranked list on Day -1 and redistributing demographic list to clinic team; works with pharmacist to ensure randomization according to protocol;
  • Sends appointments to medical team members for all dosings and IMVs, inclusive of pre-dose activities, vitals, ECG interpretations, etc.
Study Commencement
  • Present on dosing day, to ensure randomization is performed; subjects' arm bands and case books/head boards are labeled with randomization numbers prior to dosing;
  • Works with assigned study monitors to ensure availability of documents, corrections/adjustments made, memos to files are written as needed (prepares drafts for PI/Medical Director review)
  • Ensures that Medical Monitor Review Forms are prepared and sent to Assigned medical monitor and returned to PRA in a timely manner; two copies are printed and marked certified; one is given to CPCA for filing with subject's source documents/one copy is placed in regulatory binder
  • Works with medical team members to ensure on-study labs are coded in a timely manner and then presented to CPCA personnel for inclusion in study binders


United States-Kansas-Lenexa