Precision Medicine Operations Lead – FSP

• Participate in cross-functional study team meetings and workstreams to support precision medicine strategy delivery
• Support clinical study teams as a subject-matter expert on sample management and testing
• Anticipate challenges, manage project risks, and respond to internal and external stakeholder queries
• Develop and review sample-related sections of clinical protocols, informed consent forms, and sample management guidelines
• Support creation and validation of specialty laboratory databases 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
• Liaise with stakeholders on biosample vendors, proposals, bids, and contractual scope
• Forecast operational costs and timelines; manage budgeting, invoicing, and reporting
• Determine how biomarker data will be captured, blinded, transferred, and reported
• Develop and review data transfer specifications and related documents
• Guide and train clinical teams and investigative sites on biospecimen collection, storage, and shipment
• Ensure human sample transfers are documented, tracked, used, and destroyed according to SOPs and regulations
• Oversee clinical trial supplies, logistics, kit inventories, sample tracking, data query resolution, regulatory submissions, import/export documentation, LIMS, and function-specific metrics
• Support clinical study logistics strategies, emerging technology evaluation, and vendor evaluation
• Develop tools and dashboards for biomarker samples, kits, logistics, and laboratory data when acting as programming lead
• 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

• 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
• Working knowledge of ICH, GCP guidelines, and US FDA and/or local country regulations as applicable
• 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, as well as familiarity with APIs and Linux/Unix environments, if acting as programming lead for supplies and laboratory operations
• Bachelor degree in life sciences or equivalent (i.e., science, technology, engineering, or mathematics) or relevant work experience
• Biology or equivalent major preferred

• No specific benefits, perks, or compensation extras stated
• Travel not expected but may occur periodically