Ref #: 30663

Employment type: Permanent - Full-Time

Location: Durham, NC (Remote)

Posted: 14-Jul-2021

Description

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.

Line Manager

Responsibilities:
• 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 sponsor in performing oversight in fulfilling its site management activities and obligations in relation to clinical studies as the primary sponsor of those studies.
• Create a culture of process improvement with a focus on streamlining processes adding value to our business and meeting client needs
• Travel (approximately 50%) domestic and international
• In addition to work according to and comply with relevant ICON/DOCS procedures and processes

Line Management Activities:
• Act as point of contact for SponsorCTOM
• 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 Sponsor's 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 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 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
• Supervise administrative processes including document preparation, filing and archiving according to GCP and SOPs
• Supervise CRS related study start up process locally
• Supervise translation process
• Supervise eTMF process

Knowledge:
• Clinical trial processes and operations
• ICH/GCP Guidelines plus local codes of practice as applicable

Experience:
• For CRA LM: experience as CRA manager, project manager or equivalent job role

Basic qualifications (meet 100%):
• 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

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.