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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in biospecimen management, including lifecycle oversight, operational planning, and compliance with regulatory standards. Proven ability to lead cross-functional teams and manage vendor relationships effectively within clinical research environments.
Highest-signal resume keywords
Biospecimen Lifecycle ManagementClinical Trial ConductVendor OversightProject ManagementRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Biosample Operations ManagementLaboratory OperationsBiomarker WorkflowsBioanalytical Sample ManagementBudget PlanningRisk AssessmentProtocol DevelopmentSample LogisticsClinical Sample OperationsGCP Requirements
Soft Skills
Problem-SolvingDecision-MakingStakeholder EngagementAttention to DetailCollaborative Mindset
Tools & Technologies
Microsoft Office ApplicationsClinical Trial Management Systems
Industry Keywords
ICH-GCPGCLPBiobanking RegulationsClinical ResearchPharmaceuticalBiotechnologyCRO Environment
About the role
Key responsibilities & impact- Lead the operational planning, implementation, and execution of biospecimen management activities across assigned clinical studies and programs.
- Provide strategic input on biosample collection strategies, operational feasibility, logistics, and study execution plans.
- Serve as the primary Study Team point of contact for all biosample operations activities, including biomarker and bioanalytical sample management.
- Develop, maintain, and continuously optimize Biosample Operations Plans throughout the clinical trial lifecycle.
- Lead cross-functional biospecimen operational teams and facilitate governance, planning, and risk management meetings.
- Ensure alignment of biosample activities with study objectives, timelines, milestones, and regulatory commitments.
- Support selection, qualification, and oversight of central laboratories, specialty laboratories, assay providers, and related vendors.
- Oversee laboratory start-up activities, sample kit management, laboratory logistics, and ongoing vendor performance management.
- Coordinate sponsors, CROs, laboratories, and study teams to deliver biospecimen-related milestones.
- Identify operational risks and drive mitigation and contingency planning.
- Ensure lifecycle oversight of biospecimens, including collection, handling, shipping, processing, analysis, storage, and reconciliation.
- Review and provide operational input to protocols, informed consent forms, laboratory manuals, study documents, and regulatory submissions.
- Lead budget planning, forecasting, vendor oversight, and financial management for biospecimen-related activities.
- Ensure compliance with ICH-GCP, GCLP, biobanking regulations, privacy requirements, ethical standards, and company procedures.
- Support audit and inspection readiness, participate in regulatory inspections, and contribute to related responses.
- Drive process improvements, standardization initiatives, and operational excellence programs.
- Act as a subject matter expert and provide guidance to study teams and stakeholders.
Requirements
What you’ll need- Bachelor's degree in Life Sciences, Biotechnology, Biology, Biomedical Sciences, Pharmacy, or a related discipline.
- Minimum 6 years of experience in clinical research, biospecimen management, laboratory operations, or clinical development within a pharmaceutical, biotechnology, or CRO environment.
- Demonstrated experience managing biosample operations and laboratory vendors within clinical trials.
- Strong understanding of biomarker, bioanalytical, central laboratory, and biospecimen workflows across global clinical studies.
- Knowledge of clinical trial conduct, GCP requirements, biospecimen governance, and applicable regulatory frameworks.
- Experience working within cross-functional global study teams and managing external vendor relationships.
- Experience supporting protocol development, laboratory specifications, sample logistics, and study execution activities.
- Strong expertise in biospecimen lifecycle management and clinical sample operations.
- Knowledge of ICH-GCP, GCLP, biobanking requirements, and related regulatory guidance.
- Ability to manage multiple studies, priorities, and stakeholders simultaneously.
- Strong project management, planning, and organizational skills.
- Excellent problem-solving, risk assessment, and decision-making capabilities.
- Strong vendor oversight and relationship management skills.
- Advanced communication, presentation, and stakeholder engagement abilities.
- Ability to influence and lead cross-functional teams without direct authority.
- High attention to detail and commitment to quality and compliance.
- Financial acumen, including budget planning, forecasting, and management of vendor contracts.
- Strong customer focus and collaborative mindset.
- Ability to work effectively across global teams and diverse cultural environments.
- Proficiency with Microsoft Office applications and clinical trial management systems.
- Excellent written and verbal English communication skills.