Clinical Laboratory Study Manager - FSP

About the role

Parexel FSP is looking for a Clinical Laboratory Study Manager based in Argentina. The role works closely with Precision Medicine leadership and cross-functional study teams to ensure quality samples and data are managed to support biomarker and non-biomarker evaluation. It involves project management oversight of sample tracking, collection, usage, destruction and data processing in line with protocols and regulatory requirements.

Key responsibilities

• Take part in cross-functional study team meetings and act as subject-matter expert on sample management and testing, anticipating risks and answering stakeholder queries
• Help develop sample sections of protocols, informed consent forms and sample management guidelines
• Support the creation and validation of specialty laboratory databases for data collection and sample kit tracking
• Plan and run biosample storage, shipping and data transfer, and oversee acquisition and testing of clinical trial samples for biomarker research, including vendor assessment and bidding
• Forecast costs and timelines, and manage budgeting, invoicing and reporting
• Work with data management and biostatistics on how biomarker data will be captured, blinded, transferred and reported, and review data transfer specifications
• Train clinical teams and sites on collection, storage and shipment of biospecimens, and ensure sample transfers are documented, tracked, used and destroyed per SOPs and regulations
• May act as clinical trial supplies and logistics lead, overseeing kit inventories, LIMS, import/export documentation and logistics strategies
• May act as programming lead, building tools and dashboards to track samples, kits and lab data, and resolving biomarker data queries and supporting database locks
• Complete required training, timesheets and expense reports, and maintain relationships across business units

Required profile

• Minimum of 6 years of clinical research experience in academia, CRO, pharma or biotech
• Bachelor's degree in life sciences or equivalent (STEM), biology or equivalent major preferred
• Working knowledge of clinical drug development, clinical databases, ICH and GCP, and US FDA and/or local regulations
• Fluent English; travel not expected but may occur occasionally

Required skills

• Microsoft Office, with strong Excel
• Python, R, Perl, SQL or other programming languages, and familiarity with APIs and Linux/Unix if acting as programming lead
• Project management in a matrix environment