Strategic Data Integrity Specialist

2 days ago

Kurnool, Andhra Pradesh, India beBeeClinical Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

Our team seeks an experienced Clinical Monitoring Leader to play a key role in driving data quality and integrity across clinical development programs.

Key Responsibilities:
  • Develop and implement risk-based quality management plans, collaborating with cross-functional teams to ensure comprehensive strategies are in place.
  • Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies to protect patient safety and data integrity.
  • Design and oversee the implementation of advanced statistical monitoring frameworks, interpreting complex data patterns and leading root cause analyses to drive operational excellence.
  • Facilitate regular meetings with key stakeholders to review study data, findings, action plans, and data cleaning activities, ensuring seamless communication and collaboration.
  • Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions, mentoring teams on best practices in data monitoring.
Requirements:
  • Bachelor's Degree in a relevant field or equivalent combination of education, training, and experience.
  • Minimum 8 years' experience in clinical monitoring, clinical trial management, or equivalent.
  • Working knowledge of ICH GCP guidelines and the clinical development process.
Preferred Qualifications:
  • Experience as a Central Monitor within a Contract Research Organization (CRO).
Skills:
  • Statistical analysis and data monitoring.
  • Risk assessment and mitigation.
  • Report writing and presentation.

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