Biomarker & Sample Operations Lead

Parexel; Uxbridge; On-site; GBP 70,000 - 90,000; Full time

Job summary

Parexel in the United Kingdom seeks an experienced professional to support precision medicine studies through cross-functional collaboration, expert advice on sample management and testing, and the development of study documents related to biospecimens.

The role covers data management coordination, biosample logistics, and collaboration with data management and biostatistics to ensure compliant, efficient sample workflows across the study lifecycle.

Qualifications

• Minimum of 6 years clinical research experience with CRO/pharma/biotech.
• Working knowledge of ICH, GCP guidelines and FDA/local regulations.
• Bachelor degree in life sciences or equivalent; biology preferred.

Responsibilities

• Participates in cross-functional study team meetings to support precision medicine strategy.
• Supports clinical study teams as SME for sample management and testing; anticipates challenges and manages risk.
• Develops and reviews sample-related sections of study documents (protocols, ICFs, sample management guidelines).
• Supports creation and validation of specialty laboratory databases for data collection and sample kit tracking.
• Manages biosample process planning, storage, shipping, and data transfer across study lifecycle.
• Oversees biomarker sample acquisition and testing, vendors, and contract scope.
• Forecasts costs and timelines; manages budgeting, invoicing and reporting.
• Develops data transfer specs; works with data management and biostatistics on data capture and reporting.
• Ensures compliance with SOPs and regulatory requirements for human samples.

Skills

Project management

Analytical skills

Communication

Interpersonal skills

English fluency

Travel flexibility

Education

Bachelor degree in life sciences

Tools

Excel

Python

R

Perl

SQL

APIs

Linux/Unix

LIMS

Job description

Parexel in the United Kingdom seeks an experienced professional to support precision medicine studies through cross-functional collaboration, expert advice on sample management and testing, and the development of study documents related to biospecimens.

The role covers data management coordination, biosample logistics, and collaboration with data management and biostatistics to ensure compliant, efficient sample workflows across the study lifecycle.