Senior Data Integrity Specialist

4 days ago

Bengaluru, Karnataka, India beBeeClinical Full time ₹ 18,00,000 - ₹ 25,00,000
Key Clinical Operations Role

The Senior Central Monitor will play a pivotal role in ensuring the integrity and quality of clinical trial data through proactive centralized monitoring activities, statistical data review, and strategic risk management.

Primary Responsibilities:
  • Lead Development of Quality Monitoring Plan: Collaborate with cross-functional teams to design and implement comprehensive quality monitoring plans tailored to each study's unique requirements.
  • Study Risk Identification: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies in consultation with functional team leads and project managers.
  • Centralized Statistical Oversight: Perform centralized statistical oversight & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance.
  • Quality Monitoring Meetings: Lead facilitation of monthly quality monitoring meetings by supporting review of study data, documenting findings, action plans, and coordinating data cleaning activities to support study deliverables.
  • Data Integrity Assurance: Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions.
Requirements:
  • Bachelor's Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience.
  • Minimum 5 years experience in clinical monitoring, clinical trial management, or equivalent.
  • Working knowledge of ICH GCP guidelines and the clinical development process.

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