Clinical Trial Manager

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

Job Description:

The clinical study manager is responsible for all operational aspects of the assigned clinical studies from initiation till closure of the studies. The successful candidate will have clinical study operational experience in phase I, II and III drug development phases and is an operational expert in the clinical study activities from start-up, execution until closure and its underlying activities. The CSM will be the operational clinical study voice for the assigned studies, both internally and externally, he or she is owning the timelines of a clinical study project and is accountable to keep the study on track. The successful candidate will excel in establishing good and effective internal and external working relationships.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.The CSM is responsible for all clinical operational aspects for the assigned global clinical studies from preparation until closure. The study responsibilities include:

• Responsible for leading and guiding and overseeing the CROs and other (lab) vendors involved in the assigned clinical studies based upon metrics and plan
• Leading CRO contracts negotiations together with the argenx vendor manager
• Providing input into and/or developing study related materials such as Clinical Protocol, Clinical Monitoring Plans, Data Management Plans, eCRF and completion guidelines, patient information and informed consent, site instructions for specimen collections, study drug order forms etc.
• Overseeing and tracking patient recruitment and pro-actively identifies ways to prevent recruitment delays
• Ensuring that study Trial Master File is maintained and up to date
• Ensuring clinical studies are conducted in compliance with ICH-GCP and other applicable legislations
• Reviewing monitoring reports, protocol deviations and data listings for studies to ensure reliable quality data are delivered and proactive identifies and solves issues/concerns
• Facilitating timely availability of investigational product supply on site and ensuring that clinical site accountability records on site are maintained
• Ensuring timely collection of documentation for adverse event safety monitoring and collaborating in submission of MedWatch reports to FDA, EMEA and other applicable regulatory authorities
• Ensuring timely SAE reporting to the responsible IRB and Competent Authority agencies according to the applicable (local) legislation.
• Establishing and maintaining good relation with clinical site and study personnel
• Co-monitoring CROs personnel upon predefined plan
• Pro-actively identifying and solving issues in the assigned clinical studies and timely escalating them to Project Manager, Head of Clinical Operations or Senior Management, if needed
• Leading and guiding the internal clinical study team and chairing study team meetings
• Communicating in a transparent, clear way and motivating team members to work towards achieving clinical study goals
• Preparing of study timelines and budget and delivering studies within timelines, scope and budget, aligned with the clinical development plan
• Ensuring that the assigned studies are executed according to the argenx quality standards
• Responsible for risk management of the assigned studies: performing (pre-)study risk assessment and ensuring that mitigation steps for potential risks are taken
• Responsible and contact person during inspections/audits for the assigned studies together with the Quality Assurance representativeThe CSM will also participate in activities other than study-related which include but are not limited to:
  • Providing input to the clinical development strategy/plan
  • Co-writing/maintaining SOPs within the Clinical Operations department
  • Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical study
  • Experience with tools and systems for managing clinical studies (MS project, study progress and metric systems, eCRF databases)
  • Bachelors degree or University degree medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience
  • Minimum of 5 years of experience in Clinical Operations and managing CROs and vendors
  • Biotech experience is a plus
  • Auto-immune and/or oncology clinical study background is a plusBenefits 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, Honolulu , Clinical Trial Manager, Healthcare , Honolulu, Hawaii