Job Description

Position Title: Supervisor – Remote Accessioning

Location: Pune, India

Department: Data Operations / Biorepository Support

Position Summary

The Supervisor of the Remote Accessioning team is responsible for ensuring the accuracy, integrity, and regulatory compliance of data processes that support Biorepository Technicians in the timely accessioning of biological samples. This role involves managing a team dedicated to data entry and coordination, optimizing workflows, and enhancing data quality through collaboration with cross-functional teams. The Supervisor will lead initiatives to improve operational efficiency, provide comprehensive training and mentorship to team members, and develop performance metrics to monitor team progress. A background in data analytics or a related discipline is preferred, along with demonstrated leadership capabilities and experience in clinical trial or clinical research data management.

Key Responsibilities

Data Operations

• Oversee daily operations and task prioritization for the Remote Accessioning team.
• Monitor incoming shipment notifications and ensure timely creation of shipment batches in BSI.
• Upload relevant shipment data into the system and pre-enter sample metadata for kitted studies.
• Identify and flag data discrepancies in accordance with established protocols.
• Support ad hoc requests for analysis and other duties as assigned.

Data Governance

• Manage the data entry process, including the development of guidelines, training programs, and quality assurance measures.
• Collaborate with the Biorepository team to align priorities and ensure efficient workflow.
• Maintain comprehensive records of accessioning activities to support audit readiness.
• Contribute to process improvement initiatives aimed at simplifying and automating complex procedures.
• Ensure compliance with Good Clinical Practices (GCP) and applicable regulatory standards.

Leadership

• Lead cross-functional and organization-wide initiatives as required.
• Ensure all team members receive adequate training and support.
• Foster a collaborative and goal-oriented team environment.
• Assign tasks, set clear expectations, and provide constructive feedback.
• Maintain effective communication with Data Operations, functional leads, project managers, and other stakeholders.
• Assess project timelines and resource requirements, providing input as needed.

Qualifications

Minimum Requirements

• Minimum of 6 years of relevant experience.
• At least 3 years of leadership or supervisory experience.
• Proficiency in managing diverse clinical research tasks.
• Comprehensive understanding of drug, device, and/or biologic development processes.
• Experience with clinical database management systems.
• Strong expertise in data quality standards and practices.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Excellent organizational, written, and verbal communication skills in English.

Preferred Qualifications

• Background in clinical, scientific, or healthcare disciplines.
• Familiarity with data privacy regulations (e.g., GDPR, HIPAA).
• Experience with Power BI, Power Query, and/or Power Automate.
• Knowledge of Laboratory Information Management Systems (LIMS) and Biospecimen Inventory Systems.
• Experience using Smartsheet for project tracking and collaboration.