Data Integrity Specialist

1 week ago

Nagpur, Maharashtra, India beBeeClinical Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Senior Clinical Operations Leader

The Senior Clinical Operations Leader plays a pivotal role in driving data integrity, patient safety, and operational excellence across clinical development programs.

Key Responsibilities
  • Develop Centralized Monitoring Plans: Collaborate with cross-functional teams to design comprehensive centralized monitoring plans tailored to each study's needs.
  • Study Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies.
  • Advanced Statistical Monitoring: Design and oversee the implementation of advanced statistical monitoring frameworks.
  • Centralized Monitoring Meetings: Lead facilitation of monthly centralized monitoring meetings, bringing together key stakeholders to review and discuss study data.
  • Data Quality Assurance and Oversight: Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions.
  • Collaboration: Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management.
Qualifications
  • Bachelor's Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/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
  • CRO experience as a Central Monitor.
Skills
  • Statistical analysis and data monitoring
  • Risk assessment and mitigation
  • Report writing and presentation
  • Collaboration and teamwork

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