Central Clinical Data Specialist

1 day ago

Davangere, Karnataka, India beBeeClinical Full time ₹ 80,00,000 - ₹ 1,50,00,000
Job Opportunity

We are seeking a highly skilled Clinical Monitoring Expert to play a pivotal role in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management.

The ideal candidate will possess a strong understanding of ICH GCP guidelines and the clinical development process, with the ability to conduct thorough risk assessments for clinical studies and develop mitigation strategies in consultation with functional team leads and PM.

In this key position, you will perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance. You will also support monthly RBQM meetings by reviewing study data, documenting findings, action plans, and coordinating data cleaning activities to support study deliverables.

A critical aspect of this role is ensuring the highest standards of data quality and integrity through proactive monitoring and timely interventions. The successful candidate will work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies.

Additional responsibilities include preparing detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams. You will also oversee operational study metrics, including data entry trends, SDV backlog, site health trending, and proactively communicate issues to study team members to drive towards resolution & proactive remediation.

Key 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 2 years experience in clinical monitoring, clinical trial management, or equivalent.
  • Working knowledge of ICH GCP guidelines and the clinical development process.

We are looking for candidates who possess excellent collaboration and teamwork skills, with the ability to adapt to changing priorities and deadlines. If you are a motivated and detail-oriented individual with a passion for clinical monitoring, we encourage you to apply for this exciting opportunity.

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