[Hiring] Clinical Laboratory Study Manager @Parexel

Role Description

The Clinical Laboratory Study Manager works closely with Precision Medicine Leadership and cross-functional study teams to ensure quality samples and data are proficiently managed to support biomarker and non-biomarker evaluation.

• Participates in cross-functional study team meetings and workstreams to support the delivery of the precision medicine strategy for the assigned studies.
• Supports clinical study teams as subject-matter expert for technical and operational matters related to sample management and testing.
• Works with clinical study teams on the development and review of sample-related sections of study-specific documents.
• 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, including storage, shipping, and data transfer.
• Oversees the acquisition and testing of clinical trial samples designated for biomarker research.
• Forecasts operational costs and timelines, and manages budgeting, invoicing, and reporting for study-related operations.
• Works closely with data management and biostatistics leads to determine how biomarker data will be captured, blinded, transferred, and reported.
• Provides guidance and training to clinical teams and investigative sites regarding collection, storage, and shipment of biospecimens.
• May have a dedicated role as clinical trial supplies and logistics lead, accountable for samples, kits, data operations, and processes.
• May have a dedicated role as programming lead for clinical supplies and laboratory operations.
• Complies with timely completion of required training curriculum and maintains effective relationships with other platform lines.

Qualifications

• Minimum of 6 years clinical research experience with academic, Contract Research Organization, pharmaceutical or biotech industry.
• Requires bachelor degree in life sciences or equivalent (i.e., science, technology, engineering, or mathematics) or relevant work experience.
• Biology or equivalent major preferred.

Requirements

• Strong project management and organization skills in a matrix environment.
• Analytical and problem-solving experience.
• Excellent written and verbal communication skills.
• Effective communication and interpersonal skills, with proven ability to build relationships internally and externally.
• Fluent in speaking/writing English.
• Proficiency in Microsoft Office applications, including strong Excel knowledge.
• Proficiency in Python, R, Perl, SQL or other programming languages.
• Familiarity with APIs and Linux/Unix environments, if acting as programming lead for supplies and laboratory operations.
• Working knowledge of clinical drug development process and clinical databases, as well as ICH, GCP guidelines, and US FDA and/or local country regulations.

Company Description