Lead, Bio Sample Operations - Global Trials

Eli Lilly and Company; Indianapolis (IN); Presencial; USD 153 000 - 268 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Bonus program

401(k) plan

Comprehensive benefits

Resumo da oferta

Eli Lilly and Company is seeking an Advisor, Bio Sample Operations (Senior Manager level) to plan and deliver clinical biosample activities across multiple programs. You will ensure on-time, compliant execution of biosample strategies supporting safety testing, PK analysis, and biomarker assessments.

In a global, cross-functional setting, you will partner with Clinical Operations, Bioanalytical Sciences, Quality, Regulatory, and vendors to optimize sample logistics and lifecycle management while

Qualificações

• Bachelor's degree in life sciences or related field.
• 8+ years in pharma/biotech/CRO or clinical research environments.
• Experience in clinical trial operations and biospecimen management.
• Proven project management skills in a matrix organization.
• Experience with cross-functional teams and external vendors.
• Strong knowledge of GCP and regulatory standards.
• Experience with LIMS or bio-sample management systems.
• Willingness to travel 10–20%.

Responsabilidades

• Lead bio sample operations across clinical studies from start-up to final disposition.
• Translate protocol requirements into study-specific bio sample strategies and plans.
• Oversee end-to-end bio sample lifecycle including collection, processing, labeling, shipment, storage, and analysis.
• Coordinate cross-functional teams and external partners to meet timelines and budgets.
• Manage laboratories, biorepositories, couriers, CROs, and other vendors with contracts and SLAs.
• Maintain traceability and chain of custody across systems and records.
• Identify and resolve operational and quality issues including CAPAs and audits.

Conhecimentos

Project management

Cross-functional collaboration

Vendor management

GCP knowledge

Biorepository operations

Formação académica

Bachelor's degree in life sciences

Ferramentas

LIMS

Clinical data systems

Descrição da oferta de emprego

Eli Lilly and Company is seeking an Advisor, Bio Sample Operations (Senior Manager level) to plan and deliver clinical biosample activities across multiple programs. You will ensure on-time, compliant execution of biosample strategies supporting safety testing, PK analysis, and biomarker assessments.

In a global, cross-functional setting, you will partner with Clinical Operations, Bioanalytical Sciences, Quality, Regulatory, and vendors to optimize sample logistics and lifecycle management while