Biospecimen Operations Lead
Job Overview
The Biospecimen Operations Lead is responsible for the strategic planning, operational oversight, and end-to-end management of biospecimen activities across assigned clinical studies and development programs. This role serves as the primary point of contact for all biosample operational activities, including biomarker, bioanalytical, central laboratory, and sample management operations.
Working closely with Study Teams, Clinical Operations, laboratory partners, CROs, and external vendors, the Biospecimen Operations Lead ensures that biosamples are collected, processed, transported, analyzed, and stored in compliance with regulatory requirements and quality standards. The role balances scientific objectives, patient burden, operational feasibility, timelines, and budget considerations to support successful clinical trial delivery and data generation.
Key Responsibilities
- 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 regular governance, planning, and risk management meetings.
- Ensure alignment of biosample activities with overall study objectives, timelines, milestones, and regulatory commitments.
- Support the 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 activities between sponsors, CROs, laboratories, and study teams to ensure delivery of biospecimen-related milestones.
- Proactively identify operational risks and drive mitigation and contingency planning to minimize impact on study delivery.
- Ensure full lifecycle oversight of biospecimens, including collection, handling, shipping, processing, analysis, storage, and reconciliation activities.
- Review and provide operational input to protocols, informed consent forms (ICFs), 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 activities, participate in regulatory inspections, and contribute to responses related to biospecimen operations.
- Drive process improvements, standardization initiatives, and operational excellence programs within Clinical Operations and Biospecimen Management functions.
- Act as a subject matter expert for biospecimen operations and provide guidance to study teams and key stakeholders.
Qualifications
Required Experience
- 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.
Skills & Competencies
- 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.
Preferred Background
Candidates may come from roles such as:
- Biospecimen Operations Lead
- Biosample Manager
- Biomarker Operations Lead
- Central Laboratory Manager
- Clinical Sample Operations Manager
- Bioanalytical Operations Lead
- Translational Medicine Operations Lead
- Laboratory Operations Manager
- Clinical Operations Manager (Biosamples)
- Biospecimen Program Manager
This role provides the opportunity to play a critical part in the successful delivery of innovative clinical programs by ensuring the highest standards of biospecimen quality, operational excellence, patient focus, and regulatory compliance throughout the clinical development lifecycle.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.