Biosample Operations Manager - Remote Based in CANADA

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.

hat will you be doing?

• The Biosample Operations Manager plans and coordinates all operational activities for the collection, handling, storage and delivery of biomarker, pharmacogenetic, immunogenicity and pharmacokinetic samples (in following: “biosamples”) within Phase I to III clinical study, while being simultaneous assigned to multiple studies.
• The Biosample Operations Manager provides sound biosample management expertise to the study management team and is accountable for ensuring that biosamples collected are of optimal analyzable quality and are collected in adherence to the highest standards and informed consent.
• The Biosample Operations Manager is responsible for training of investigational sites on all topics regarding biosample handling.
• The Biosample Operations Manager is the primary interface for operational activities between the study management team and laboratories performing biosample analysis and is the first point of contact for the monitors regarding all aspects of biosample handling.
• Geographical scope: Global
• Responsibilities of position Plans, organizes, monitors and enforces the collection, processing, storage and logistics of biosamples within a study. Accountable for preparation of study related documents (biosample management plan, laboratory manual, sample handling sheets etc.) as well as development of shipment schedules, sampling and storage requirements in close collaboration with central and analytical laboratories. Responsible for the tracking, monitoring and documentation of biosampling activities. Responsible for handling of samples according to protocol, SOPs, GCP and ICH-guidelines.
• Training of monitors, study nurses and investigators. Supports the study team with the submission to IRBs and ECs and responds to IRB/EC requests.
• Work relations The most important internal work relationships are with members of the Clinical Teams, especially the Clinical Pharmacokineticist, Bioanalysts, the Biomarker Project Leader, Assay Technology Expert, CPLs/ECLs, Study Lead Monitors, Study Data Managers and Study Managers as well as the Strategic Outsourcing Managers. The most important external work relationships are with CROs selected and contracted for central laboratory support, site staff involved in clinical trials (investigators, study nurses), analysis laboratories and Institutional Review Boards or Ethics Committees.

What do you need to have?

Education required:

• Bachelor’s degree in a health, life sciences or other relevant field of study

Skills required:

• 5 years’ relevant experience

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.