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Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research, particularly in biosample management and biomarker data handling, while ensuring compliance with ICH, GCP, and FDA regulations. Proficient in project management, data analysis, and effective communication across cross-functional teams.
Highest-signal resume keywords
Clinical Research ExperienceProject Management SkillsKnowledge of ICH and GCP GuidelinesProficiency in Python, R, SQLStrong Communication Skills
Tech Stack
Tools & technologiesAbout the role
Key responsibilities & impact- Participate in cross-functional study team meetings and workstreams supporting precision medicine strategy
- Support clinical study teams as subject-matter expert for sample management and testing
- Anticipate challenges, manage project risks, and respond to internal and external stakeholder queries
- Develop and review sample-related sections of study documents, including clinical protocols, ICFs, 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
- Assess biosample vendors, review proposals and bids, and define contractual scope
- Forecast operational costs and timelines; manage budgeting, invoicing, and reporting
- Determine how biomarker data is 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
- Manage clinical trial supplies, logistics, samples, kits, data operations, vendor management, and related processes when assigned
- Oversee kit inventories, sample collection and tracking, data query resolution, regulatory submissions, import/export documentation, proforma invoices, LIMS, and functional metrics
- Create, implement, monitor, and improve clinical study logistics strategies
- Develop tools and dashboards for biomarker samples, kits, logistics, and laboratory data when acting as programming lead
- Aggregate, extract, process, and assess confidential data using technical tools, systems, and programming languages
- 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, business, research, and enabling lines
Requirements
What you’ll need- 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 and GCP guidelines
- Working knowledge of US FDA and/or local country regulations as applicable
- Bachelor's degree in life sciences or equivalent (science, technology, engineering, or mathematics) or relevant work experience
- Biology or equivalent major preferred
- Fluent in speaking/writing English
- 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
- Proficiency in Microsoft Office applications, including strong Excel knowledge
- Proficiency in relevant role-specific systems
- Proficiency in Python, R, Perl, SQL or other programming languages, plus familiarity with APIs and Linux/Unix environments, if acting as programming lead
- Travel not expected but may occur periodically
Benefits
Comp & perks- Home-based work from a home office
- Time for outside life
- Annual performance-based bonus plan eligibility for eligible roles
- Annual salary review
- Total rewards incentives for eligible roles
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical ResearchBiosample ManagementData AnalysisBiomarker ResearchSample Management GuidelinesDatabase ManagementBudgeting and InvoicingRegulatory ComplianceData Transfer SpecificationsLogistics Management
Soft Skills
Analytical SkillsProblem-Solving SkillsInterpersonal SkillsOrganizational SkillsRelationship Building
Tools & Technologies
Microsoft OfficeExcelLIMSAPIsLinux/Unix
Industry Keywords
Clinical Drug DevelopmentContract Research OrganizationPharmaceutical IndustryBiotech IndustryHuman Sample Transfers