Senior Clinical Trial Manager (East Coast) Remote

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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.

What you will be doing:

• 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 representative

You are:

The CSM will also participate in activities other than study-related which include but are not limited to:

• 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)
• Bachelor’s 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 globally
• Biotech experience is a plus
• Auto-immune and/or oncology clinical study background is a plus
• Providing input to the clinical development strategy/plan

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.