Biomarker Data Specialist

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.

The Biomarker Data Specialist is responsible for supporting oversight of clinical specimens and associated laboratory data collected throughout the life of a clinical trial, including safety labs, PK, biomarkers, tumor samples, etc. and will assist in departmental infrastructure development. The BDS will engage with cross-functional team members while developing data management skills and helping coordinate lab vendor start-up and study maintenance with support and oversight. The BDS has at least a preliminary understanding of clinical laboratory/ biomarker testing, lab specimen handling and lab data reconciliation. A working knowledge of FDA regulations and general industry standards is desired.

• Support laboratory data management procedures including authoring and reviewing data transfer plans, overseeing data transfers, processing and storage of data. Use templates and standard guidelines to initiate documents but exercises critical thinking and discretion to tailor documents to study needs.
• Support data cleaning activities for lab data reconciliation. Research and resolve discrepancies of moderate complexity.
• Assist lead Biomarker Data Specialists to create detailed specifications for tabular and unstructured data by working with various stakeholders to ensure appropriate metadata variables and fit-for-purpose data structure meet end user needs.
• With guidance, assist in managing multiple project streams by coordinating with internal and external stakeholders concerning timelines and deliverables. Internal stakeholders may include Clinical Pharmacologists, Biomarker & Bioinformatics scientists, Clinical Specimen Coordinators, Clinical Project Managers and others. External stakeholders may include vendor representatives such as Project Managers, Data Analysts and others.
• Advise and coordinate with clinical project managers, scientists, external vendor contacts, programmers, analysts and other stakeholders regarding timelines and deliverables
• Work with internal and external stakeholders to coordinate specimen testing in accordance with study plans and timelines.
• Maintain an integrated tracking and inventory log of all specimens collected during a clinical trial, interpret data and share metrics with stakeholders.

• Conduct data cleaning activities for vendor data reconciliation with minimal guidance. Exercise discretion and seek guidance as needed to choose efficient and effective issues resolution paths.
• With some oversight, create detailed specifications for tabular and unstructured data by working with various stakeholders to ensure appropriate metadata variables and fit-for-purpose data structure that meet end user needs.
• Run SAS programs, review SAS logs, and generate output.
• Utilize problem-solving skills when working with vendors and collaborators to drive projects forward, seeking guidance when needed.
• Draft, revise, and provide feedback on contracts and study documents to ensure alignment with stakeholders needs, internal processes and vendor capabilities.
• Work with external labs and internal stakeholders to troubleshoot issues and implement process improvements of moderate scope.
• Assist in maintenance of department tools, templates, and systems.

• Years of experience: 3– 5 years; dependent on level of related skills and education
• Laboratory background and/or working knowledge of commonly tested biomarkers in the oncology setting, latest and advanced analytical tools and assays
• Prior experience writing specification documents and/or work instructions
• Proficiency with Excel
• Technologically savvy; quickly picks-up on new information, standards, regulations, tools, methods or software as it relates to position and profession
• Detail oriented; performs quality and accurate work
• Excellent written/verbal communication skills
• Flexible, easily adapts to change, and is energized by challenges and problem-solving
• Effective time management skills and ability to prioritize successfully
• Ability to coordinate multiple projects and tasks
• Preferred:
  • Previous sample tracking and/or handling experience
  • Previous Electronic Data Capture (EDC) experience
  • Previous LIMS (Laboratory Information Management System) experience
  • Working knowledge of the clinical drug development process
  • Working knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development and UAT
  • Oncology experience and/or working knowledge

Education

• BA/BS in relevant field; years of experience may substitute for education

Competencies

• Manages complexity
• Decision quality
• Communicates effectively
• Collaborates
• Manages ambiguity
• Nimble learning
• Tech savvy
• Cultivates innovation
• Customer focus
• Balances stakeholders
• Action oriented

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.