United States Other 6 days ago

Overview

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.

Responsibilities

We are seeking a highly motivated professional to join our Biomarker Operations group to work in a dynamic and cross-functional environment spanning early to late-stage clinical development. The Specialist, Biomarker Operations acts as an important contributor to clinical development of novel therapies to treat rare diseases.In this position you will coordinate timelines and activities for biomarker projects and communicate across all relevant departments to ensure high quality and timely delivery of biomarker results. This role will closely collaborate with biomarker leads, clinical trial operations, medical, data management, biostatistics, and external laboratory vendors/CROs. Core duties of this role include biomarker sample operational logistics, clinical trial support, and management of biomarker vendors.Responsibilities:
  • Work with colleagues in Biomarkers and Imaging for the implementation of biomarkers in pre-clinical validation and clinical studies to meet program goals through a translational understanding of the disease state and treatment modalities
  • Maintain close contact with the Biomarker and Imaging program leadership to communicate biomarker activities
  • Serve as a key member of clinical study execution teams, providing input and guiding clinical implementation of biomarkers
  • Develop biomarker sample handling guideline for sample processing and manage aspects of biomarker sample collection and consent
  • Track and trigger analyses of biomarker clinical samples to completion and data transfers according to established timelines
  • Resolve biomarker sample related questions from sites, CROs, clinical operations, and ethics committees with cross-functional team input (e.g. stability, sample usage, storage duration)
  • Manage work with CROs on biomarker assays (for pre-clinical validation or for clinical trials) including contract management, scope of work, lab manual, biomarker analysis plan, development of timelines, and oversight of deliverables
  • Responsible for long term storage and destruction of biomarker samples from clinical or exploratory studies
  • File expected biomarker documents in sponsor Trial Master File (TMF)
  • Review clinical trial study documents including study dossier, version control tracker, vendor management plan, and Action Decisions Risks log and update as applicable.
  • Creates template documents for Biomarker Operations team as well as training materials for new team members
  • Assist with on-boarding and training new Biomarker Operations team members

Qualifications

  • BS in Biology or related field with approximately 4 years or more of experience or the equivalent combination of education and experience
  • Excellent written and oral communication; organized and detail-oriented; ability to prioritize and plan
  • Knowledge and understanding of general scientific principles as applied to biomarker research, development, and implementation
  • Knowledge of Good Clinical Practices, clinical study design and implementation is a plus but not required

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.
  • Company:
    PRA Health Sciences
  • Job Type:
  • Posting Date:
    12th May 2022
  • Valid through:
    12th Jun 2022
  • Location:
For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. By applying to a job using RedHired you are agreeing to comply with and be subject to the RedHired Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.