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Posted: 10/16/2026Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research project management, including sample management, data collection, and compliance with regulatory standards. Proficient in programming languages and tools for data processing and analysis, with strong communication skills for stakeholder engagement.
Highest-signal resume keywords
Clinical Research ExperienceProject Management SkillsProficiency in Python, R, Perl, SQLKnowledge of ICH and GCP GuidelinesBachelor Degree in Life Sciences
Tech Stack
Tools & technologiesAbout the role
Key responsibilities & impact- Participate in cross-functional study team meetings and workstreams to support precision medicine strategy delivery
- Support clinical study teams as subject-matter expert for sample management and testing, anticipating challenges, managing project risk, and responding to stakeholder queries
- Develop and review sample-related sections of 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 throughout the study lifecycle
- 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
- Work with data management and biostatistics leads on biomarker data capture, blinding, transfer, and reporting
- Develop and review data transfer specifications and related documents
- Provide guidance and training on biospecimen collection, storage, and shipment
- Ensure human sample transfers are documented, tracked, used, and destroyed according to SOPs and regulations
- Lead or support clinical trial supplies and logistics, including samples, kits, data operations, global logistics, and specialty vendor management
- Manage kit inventories, sample collection and tracking, data query resolution, regulatory documents, import/export documentation, LIMS, and function-specific metrics
- Create, implement, monitor, and improve clinical study logistics strategies for precision medicine deliverables
- Support development of tools and dashboards for biomarker samples, kits, logistics, and laboratory data
- 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
Requirements
What you’ll need- 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
- Travel not expected but may occur periodically
- 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
- 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
- Requires bachelor degree in life sciences or equivalent (i.e., science, technology, engineering, or mathematics) or relevant work experience
- Biology or equivalent major preferred
Benefits
Comp & perks- No explicit benefits, perks, or compensation extras stated
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Sample ManagementData CollectionBudgeting and InvoicingBiomarker Data CaptureDatabase ManagementClinical Trial LogisticsRegulatory ComplianceData Transfer SpecificationsBiospecimen CollectionOperational Cost Forecasting
Soft Skills
Analytical SkillsProblem-Solving SkillsEffective CommunicationInterpersonal SkillsRelationship Building
Tools & Technologies
Microsoft OfficeLIMSAPIsLinux/Unix EnvironmentsSpecialty Laboratory Databases
Industry Keywords
Clinical Drug Development ProcessContract Research OrganizationBiotech IndustryUS FDA RegulationsICH GuidelinesGCP Guidelines