Regulatory compliance

3 weeks ago


Pune, India Precision Medicine Group Full time

Position Title: Supervisor – Data Support Operations Department: Data Operations / Biorepository Support 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. Data Operations Oversee data modification 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. 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. Ensure compliance with Good Clinical Practices (GCP) and relevant regulatory standards. Provide training, support, and mentorship to team members. Maintain effective communication with internal stakeholders and project teams. Assess project timelines and resource needs, offering strategic input. Minimum 6 years of relevant experience. Proficiency in clinical research operations and data management. Experience with clinical database systems and data quality standards. Proficiency in Microsoft Office Suite (Word, Excel, Power Point, Outlook). Excellent organizational, written, and verbal communication skills in English. Background in clinical, scientific, or healthcare disciplines. Familiarity with data privacy regulations (e.g., 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. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice . Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at



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