Clinical Sample Manager

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.

ICON ISS is searching for a Clinical Biosample Manager in the US - East Coast. This is a remote based position but may require occassional travel to the sponsor offices in Boston, MA. 

• Plan, implement, manage and drive biological sample logistics within Phase I-IV Clinical Trials.
• Deliver and implement the biosample strategy within multiple clinical programs in accordance with the requirements of quality, ethical and regulatory standards including ICH/GCP/GLP
• Coordinate and lead the Clinical Trial Management Biosamples operational activities at the program/trial level to ensure appropriate resource, training and support for Biosample logistics activities
• Ensure the Clinical Trial Management Biosamples Team continuously maximizes biosample sample accrual and quality.
• Ensure standardization and harmonization of Biosample activities across clinical trials and oversight of sample collection, processing, storage, and reconciliation.
• Ensure project level consistency occurs for biosampling across studies and is the primary point of contact within Clinical Trial Biosample Management for project, clinical and study teams.
• Leads or contributes to innovation and continuous improvement activities in the area of biosample collection, processing and data delivery.
• Responsible for managing logistical set up and operational implementation of Biosample / translational research activities in a clinical study. Will act as trial team member under the leadership of the Clinical Trial Leader (CTL), executing trial level biosample related activities in accordance with study objectives and timelines

• Bachelor degree (or equivalent) in life sciences (e.g. biology, chemistry, pharmaceutics) or medicine, or a related medical field
• Certification in clinical research (US: ACRP or other certification), or bachelor or master degree in clinical research/clinical trial management highly desirable
• Excellent command of English language (verbal, written and listening)
• Requires approximately 4-6 years of experience for this role. At least 2 year experience in clinical project management (e.g. Associate Clinical Trial Biosample Manager, Clinical Trial Manager, or pertinent comparable position)
• Profound experience in leading and managing biosample operational activities essential on a range of logistically complex multi-location clinical studies; clinical trial planning and start up (including budget & resource planning) desirable;
• Advanced knowledge of ICH-GCP, other relevant Guidance documents (from ICH, FDA, EMEA etc.), and of regulations and requirements for clinical trial authorization and tissue storage and transfer in major countries
• Proven ability to successfully achieve results leading teams within a multi-cultural and geographically diverse matrix environment
• Knowledge of legal and regulatory environment related to human specimen collection, analysis and retention
• Proven track record in training, mentoring, supporting and coordinating of staff essential
• Project management skills desirable, willing to take on and lead special projects, able to identify risks and problems and to propose appropriate measures when required
• Excellent IT, presentation, time management and interpersonal skills

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.