ICON is looking for a CRA Line Manager in the Northeat Region to support one of our FSP programs. The role of the Line Manager is to line manage CRAs and/or CTAs effectively, ensuring high performance, quality and continuous development. Including interviewing, evaluating and selecting CTAs and CRAs. To assist in performing oversight in fulfilling its site management activities and obligations in relation to clinical studies as the primary sponsor of those studies.
What you will be doing:
Line Management Activities:
Act as point of contact for Amgen CTOM
Manage key activities as needed to cover CRA/CTA absence
Perform CRA accompanied visits within 3 months of CRA onboarding and routinely thereafter
according to the Quality Oversight Plan
Conduct activities detailed in the Quality Oversight Plan
Interact with strategic partners (KOLs, Investigators and Site Staff) as necessary for execution of
clinical trials and reinforcement of clients brand
Ensure FSP staff achieve expected quality compliance standards with all appropriate SOPs, policies,
regulations and guidelines, including spot check review of reports and spot co-monitoring with CRAs
Support FSP staff to achieve delivery of study objectives
Supports CRAs with resolution of significant site issues and development of recruitment strategies
Ensures that CRAs and CTAs are qualified and trained, both in clinical studies execution and in clients
policies and procedures, to provide data that meets quality requirements
Provide leadership in the continuous improvement in CRA and CTA performance and monitoring
processes
Support staff with action plan development and resolution of findings from Clinical Quality Assurance
audits
Conduct resource planning and metrics review with clients site management
Conduct staff regular performance assessments and personal/career discussions with direct reports
Responsible for providing regular updates to Senior Management and adhering to metrics
Review and approve itineraries, expense reports, and visit reports for assigned staff
Supervise IRB/IEC and Regulatory Authority Submission process if applicable
You are:
CRA Line Management exprience needed.
BA/BS/BSc or qualified nurse (RN)
Work experience in life sciences or medically related field, including biopharmaceutical clinical research
experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical
or CRO company, or other relevant clinical setting)
Preferred qualifications:
BA/BS/BSc in the life sciences or RN
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:
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
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, colour, 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 or submit a request here.
Interested 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.
Software Powered by iCIMS
www.icims.com