Clinical Laboratory Study Manager – FSP

• Work 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
• Provide project management oversight for sample tracking, usage, collection, destruction and data processing in alignment with protocols and regulatory requirements
• Participate in cross-functional study team meetings and workstreams supporting precision medicine strategy
• Serve as subject-matter expert on sample management and testing, anticipating challenges, managing project risks and responding to stakeholder queries
• Develop and review sample-related sections of clinical protocols, Informed Consent Forms and sample management guidelines
• Support specialty laboratory database creation and validation for data collection and sample kit tracking
• Manage biosample process planning and execution, including storage, shipping and data transfer
• Oversee acquisition and testing of clinical trial samples for biomarker research and liaise with vendors and stakeholders
• Forecast operational costs and timelines; manage budgeting, invoicing and reporting
• Coordinate with data management and biostatistics leads on biomarker data capture, blinding, transfer and reporting
• Develop and review data transfer specifications and related documents
• Train clinical teams and investigative sites on biospecimen collection, storage and shipment compliance
• Ensure human sample transfers are documented, tracked, used and destroyed according to SOPs and regulations
• Potentially lead clinical trial supplies and logistics, including sample and kit inventories, logistics, vendor management, documentation and LIMS tracking
• Support precision medicine logistics strategies and evaluate emerging technologies and vendors
• Potentially lead programming for clinical supplies and laboratory operations, developing tools and dashboards
• Use technical tools, systems and programming languages to aggregate, extract, process and assess data
• Assess laboratory databases, resolve biomarker data queries and support database lock activities
• Complete required training, timesheets, expense reports and CV updates
• Maintain effective relationships across platform lines, business/research units and enabling lines

• Candidates must be based in Argentina
• 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
• Knowledge of ICH, GCP guidelines, and US FDA and/or local country regulations as applicable
• Bachelor degree in life sciences or equivalent (i.e., science, technology, engineering, or mathematics) or relevant work experience
• Biology or equivalent major preferred
• 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, as well as relevant role specific systems
• 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

• No explicit benefits or compensation extras stated
• Full-time employment
• Travel not expected but may occur periodically