Clinical Biomarker Specimen Specialist
- Location
- Remote (US)
- Listed
- Today
About the role
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
The 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.
Principal Responsibilities
- Clinical specimen management from collection through testing and final disposition.
- Ensures compliance with Clinical Protocol and Informed Consent
- Maintain chain of custody
- 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.
- Collaborate on implementation and maintenance of specimen tracking system
- Work collaboratively with internal key stakeholders (e.g. Project Management, Clinical
Additional information
Operations, Biomarker and Bioanalytical Scientific Study Leads, Data Management) to ensure proper alignment and study-level execution of specimen management.
Required Qualifications
- 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
- Effective project management and time management skills; able to prioritize successfully
- Proficiency with data sets and Excel, understanding of data relationships and metadata
- Confident in overseeing vendors and communicating with experts to drive quality deliverables
- 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
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 FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development and UAT
- Oncology experience and/or working knowledge
- Proficiency with timeline management
Education
- BA/BS in relevant field; years of experience may substitute for education
#LI-LG4
Equal opportunity and legal notices
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
From Parexel's careers page, first listed on Rolev.ai on November 15, 2026. Rolev.ai is not the employer.
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Common questions
Where is the Clinical Biomarker Specimen Specialist job at Parexel located?
Yes, this Clinical Biomarker Specimen Specialist opening at Parexel is listed as Remote (US). Always check Parexel's application page for specific state eligibility or relocation policies.
How do I apply for the Clinical Biomarker Specimen Specialist position at Parexel?
This listing links directly to Parexel's Workday application page. You can apply directly on Parexel's site, or use Rolev.ai to check your resume fit, generate a zero-hallucination tailored resume and cover letter for this posting, and autofill the Workday application form in 1 click with the Rolev.ai Chrome extension. You always review the form and press Submit yourself.