Job Description

Position Title: Supervisor – Data Support Operations

Location: Pune, India

Department: Data Operations / Biorepository Support

Position Summary

The Supervisor – Data Support Operations is responsible for overseeing the support team, ensuring the accuracy, integrity, and regulatory compliance of data processes that support that support various teams/roles including, but not limited to, sample accessioning, sample testing, project management, and data management. This role involves managing a team focused on data entry and coordination, optimizing workflows, and enhancing data quality through collaboration with cross-functional teams.

The Supervisor will lead operational efficiency initiatives, provide training and mentorship, and develop performance metrics to monitor team progress. A background in data analytics or clinical research data management is preferred, along with demonstrated leadership capabilities.

Key Responsibilities

Data Operations

• Oversee data modification requests initiated via the Ticketing System.
• Oversee E-portal requests initiated via the Ticketing System.
• Investigate and resolve data discrepancies in conjunction with project collaborators.
• Review and validate supporting documentation and mapping files for data changes.
• Conduct impact assessments to ensure accurate and complete data updates.
• Coordinate with requestors to confirm additional sample updates when necessary.
• Create and manage modification batches in BSI, ensuring traceability and audit readiness.
• Ensure data updates are accurately reflected in inventory systems and communicate resolution status to stakeholders.
• Prepare draft correspondence to record actions taken to correct data errors.
• Prepare and analyze reports from the BSI to identify possible errors in data.

Data Governance

• Train, as necessary, all data entry personnel in proper operation of all protocols.
• Manage data entry processes and develop guidelines, training programs, and quality assurance measures.
• Collaborate with Biorepository teams to align priorities and streamline workflows.
• Drive process improvement initiatives focused on automation and simplification.
• Ensure compliance with Good Clinical Practices (GCP) and relevant regulatory standards.

Leadership

• Lead cross-functional and organization-wide initiatives.
• Provide training, support, and mentorship to team members.
• Foster a collaborative and goal-oriented team culture.
• Assign tasks, set expectations, and deliver constructive feedback.
• Maintain effective communication with internal stakeholders and project teams.
• Assess project timelines and resource needs, offering strategic input.

Qualifications

Minimum Requirements

• Minimum 6 years of relevant experience.
• At least 3 years in a leadership or supervisory role.
• Proficiency in clinical research operations and data management.
• Strong understanding of drug, device, and biologic development processes.
• Experience with clinical database systems and data quality standards.
• 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.