Senior Specialist, Lab Startup and Specimen Management, Remote

Job Description

The Senior Specialist, Specimen Management & Lab Start-Up is responsible for executing and independently managing key laboratory start-up and specimen management activities across clinical trials. This role ensures that study-specific laboratory requirements are effectively implemented and that biospecimen collection, processing, shipment, tracking, and reconciliation are conducted in a compliant, timely, and high-quality manner.

The Senior Specialist acts as a subject matter resource for study teams and supports cross-functional alignment with internal stakeholders, central and specialty laboratories, and logistics providers to ensure successful study activation and execution.

Key Responsibilities:

Study Start-Up Execution:

• Lead and execute laboratory start-up activities for assigned studies, including:
• Reviewing protocols for specimen requirements and operational feasibility
• Supporting or leading lab feasibility assessments
• Coordinating central and specialty lab set-up
• Contributing to or reviewing lab manuals and study documents
• Supporting sample kit design, forecasting, and distribution
• Ensuring requisition forms and workflows align with protocol requirements
• Track and manage lab start-up timelines and deliverables for assigned studies.
• Identify risks impacting study start-up and escalate or mitigate as appropriate.

Specimen Management Operations:

• Manage end-to-end specimen lifecycle activities, including:
• Sample collection guidance and issue resolution
• Shipment coordination and tracking
• Sample receipt confirmation and chain of custody
• Specimen reconciliation and discrepancy follow-up
• Monitor specimen data for accuracy, completeness, and compliance.
• Investigate and resolve sample-related issues with sites, labs, and providers.
• Ensure high-quality sample handling across multiple sites and studies.

Provider and Laboratory Coordination:

• Serve as a key point of contact for:
• Central laboratories
• Specialty labs
• Logistics and courier providers
• Coordinate kit shipments, lab readiness, and issue resolution.
• Monitor provider deliverables and escalate performance concerns when needed.
• Ensure providers adhere to protocol-specific requirements and timelines.

Cross-Functional Collaboration:

• Partner with Clinical Operations study teams, Biomarker Managers, Pharmacokinetics, Data management, Quality and Regional teams
• Communicate specimen-related updates, risks, and issues.
• Support alignment of specimen processes with overall study execution plans.
• Provide input into study planning and operational readiness discussions.

Quality and Compliance:

• Ensure all specimen management activities comply with:
• Good Clinical Practice (GCP)
• IATA/DOT shipping regulations
• Internal SOPs and quality standards
• Support audit and inspection readiness activities.
• Document deviations and support root cause analysis and corrective actions.

Documentation and Systems:

• Maintain accurate documentation related to:
• Lab start-up activities
• Specimen tracking and reconciliation
• Provider communications
• Utilize systems such as:
• CTMS
• Sample tracking platforms or LIMS
• eRequisition tools (if applicable)
• Generate reports and metrics on specimen performance and study readiness.

Process Improvement:

• Identify opportunities to improve workflows, reduce errors, and enhance efficiency.
• Support implementation of new tools, technologies, or best practices.
• Contribute to standardization efforts across studies and programs.

Mentorship / Leadership Contributions (Informal):