Clinical Laboratory Study Manager

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Work closely with Precision Medicine Leadership and cross-functional study teams • Ensure quality samples and data are proficiently managed to support biomarker and non-biomarker evaluation • Participate in cross-functional study team meetings and workstreams • Supports project management and study set-up teams in the creation and validation of specialty laboratory databases • Manages all activities related to biosample process planning and execution • Oversees the acquisition and testing of clinical trial samples designated for biomarker research • Works closely with data management and biostatistics leads to determine how biomarker data will be captured, blinded, transferred and reported for clinical trials • Provides guidance and training to clinical teams and investigative sites regarding collection, storage and shipment of biospecimens

🎯 Requirements

• Minimum of 6 years clinical research experience with academic, Contract Research Organization, pharmaceutical or biotech industry • Working knowledge of clinical drug development process and clinical databases, as well as ICH, GCP guidelines, and US FDA and/or local country regulations as applicable • Proficiency in Microsoft Office applications, including strong excel knowledge • Proficiency in Python, R, Perl, SQL or other programming languages, as well as familiarity with APIs and Linux/Unix environments • Requires bachelor degree in life sciences or equivalent (i.e., science, technology, engineering, or mathematics) or relevant work experience

🏖️ Benefits

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development