Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Clinical Biomarker Specimen Specialist - FSP
Job ID R0000037447The Clinical Biomarker Specimen Specialist works collaboratively with the Clinical Biomarker Operations Manager, Study Managers, and Scientific stakeholders to ensure timely and smooth collection, transfer, and testing of clinical trial specimens. This role will ensure full chain of custody is maintained through the specimen lifecycle from collection through testing and final sample disposition. This role requires clinical study, specimen management, and project management experience. As well as knowledge of GxP and vendor-sponsor best practices.
Key Accountabilities:
Oversight of programming activities:
Clinical specimen management from collection through testing and final disposition
Ensures compliance with clinical protocol and informed consent.
Maintain chain of custody for specimens
Organize and oversee the collection, shipping and proper storage and maintenance of clinical specimens
Resolve and/or triage specimen queries from sites or vendors
Ensuring proper documentation of specimen destructions are obtained and filed appropriately
Collaborative relationships:
Collaborate on implementation and maintenance of specimen tracking system
Work collaboratively with internal key stakeholders (e.g. Project Management, Clinical Operations, Biomarker and Bioanalytical Scientific Study Leads, Data Management) to ensure proper alignment and study-level execution of specimen management
Compliance with Parexel standards:
Complies with required training curriculum
Completes timesheets accurately as required
Submits expense reports as required
Updates CV as required
Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements
Skills:
Effective project management and time management skills; able to prioritize successfully
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 with minimal oversight
Excellent written/verbal communication skills
Can identify opportunities for efficiency improvements and simplification, recognizes appropriate.
Resources for deliverables, has effective organizational skills
Interpersonal skills; encourages collaboration, is a team player and is cooperative, builds constructive and effective relationships, is approachable, communicates effectively
Flexible, easily adapts to change, and is energized by challenges and problem-solving
Can learn new skills and knowledge, able to offer new ideas but also willing to adapt style to existing process as appropriate
Other competencies include managing complexity and ambiguity, decision quality, collaborates, cultivates innovation, customer focus, nimble learning, balances stakeholders, and action oriented
Proficiency in written and spoken English – required
Proficiency in local languages (as applicable)
Knowledge and Experience:
Years of experience: 2-5 years; dependent on level of related skills and education
Laboratory background and/or strong knowledge of commonly tested biomarkers in the Oncology setting, latest and advanced analytical tools and assays
Proficiency with data sets and Excel, understanding of data relationships and metadata
Confident in overseeing vendors and communicating with experts to drive quality deliverables
Preferred:
Previous biobanking, sample tracking and handling experience
Previous LIMS (Laboratory Information Management System) experience
Working knowledge of the clinical drug development process
Working knowledge of the Food & Drug Administration (FDA) regulations, International Council for Harmonization (ICH) Good Clinical Practice (GCP) guidelines, Study Data Tabulation Model (SDTM), Clinical Data Interchange Standards Consortium (CDISC), database development and User Acceptance Testing (UAT).
Oncology experience and/or working knowledge
Proficiency with timeline management
Education:
Bachelor of Arts/Bachelor of Science in relevant field, or other relevant experience/qualification
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