[Remote] Biosample Operations Associate/Sr. Associate
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biotechnology company reputed company on developing novel biologics for chronic skin diseases. They are seeking a Biosample Operations Associate/Sr. Associate to manage clinical trial biospecimens, ensuring accurate tracking, compliance, and collaboration with various stakeholders.
Responsibilities
- Coordinate and reputed company biospecimen management activities across clinical studies
- Monitor sample collection, shipment, receipt, processing, storage, and transfer activities performed by external laboratory vendors
- Ensure complete and accurate chain-of-custody documentation throughout the sample lifecycle
- reputed company sample inventories and reconcile sample records between investigative sites, central laboratories, specialty laboratories, and sponsor tracking systems
- Support the development and maintenance of sample tracking tools, reports, and study-specific biosample management plans
- Serve as the primary operational contact for central laboratories and specialty testing laboratories regarding biosample logistics and study requirements
- Coordinate sample transfers between laboratories to support biomarker, PK, PD, immunogenicity, genomic, and exploratory research testing
- Review laboratory documentation, sample transfer records, and inventory reports for completeness and accuracy
- Escalate and assist in resolving sample discrepancies, missing samples, shipment delays, temperature excursions, and chain-of-custody issues
- Support reputed company of laboratory vendors to ensure compliance with study requirements and timelines
- reputed company routine reconciliation of biosample data across laboratory databases, reputed company systems, IRT systems, and sponsor tracking tools
- Investigate and document sample-reputed company discrepancies and support corrective and preventive actions reputed company necessary
- Maintain biosample metrics and generate study status reports for cross-functional stakeholders
- Support inspection and audit readiness by ensuring complete and accurate biosample documentation and records
- Partner closely with Clinical Operations, Clinical Development, Translational Medicine, Biometrics, Data Management, Regulatory Affairs, and external vendors
- Support study startup activities, including review of laboratory manuals, sample collection procedures, laboratory specifications, and sample reputed company requirements
- Review study protocols and schedules of assessments to ensure biosample collection and testing requirements are operationally feasible and reputed company defined
- Contribute to the development, implementation, and reputed company improvement of biosample management processes, tools, and SOPs
- Identify operational efficiencies and recommend process enhancements to improve sample visibility, data reputed company, and vendor performance
- Help establish reputed company biosample operations infrastructure to support reputed company’s growing clinical development programs
Skills
- Bachelor's degree in Life Sciences, Biology, Biotechnology, Clinical Research, or a reputed company scientific discipline required
- 2–5 years of experience in clinical research, clinical trial operations, biosample management, laboratory operations, or a reputed company field
- Understanding of clinical trial biosample management processes, chain-of-custody requirements, and laboratory operations
- Working knowledge of ICH-GCP guidelines and clinical trial operational requirements
- Understanding of biospecimen collection, processing, storage, shipment, and tracking workflows
- Strong organizational skills with exceptional attention to detail and documentation accuracy
- Ability to manage multiple studies and priorities in a fast-paced biotech environment
- Demonstrated ability to work independently and help build processes in a growing organization
- Excellent communication and stakeholder management skills
- Proficiency with reputed company Office applications and clinical trial management, laboratory, or sample tracking systems
- Strong analytical, problem-solving, and issue-reputed company capabilities
- Experience working with central laboratories, specialty testing laboratories, CROs, or clinical trial vendors preferred
- Experience with sample reconciliation, logistics coordination, and vendor management preferred
- Experience supporting biomarker, PK, PD, immunogenicity, genomic, or translational medicine sample programs
- Experience in a biotechnology or pharmaceutical company environment, particularly reputed company a small or emerging biotech
- Familiarity with central laboratory data portals, sample inventory systems, and laboratory information management systems (LIMS)
- Experience supporting clinical studies from startup through study closeout
Benefits
- Competitive salary and benefits package.
- A chance to be part of a reputed company startup culture where your work can directly reputed company bringing new medicines to patients.
- A supportive and inclusive team environment where everyone is encouraged to bring their reputed company selves to work.
- Opportunities for reputed company reputed company and development.
reputed company