Clinical Data Quality Assurance Specialist

2 days ago

Hubli, Karnataka, India beBeeCentral Full time ₹ 9,00,000 - ₹ 12,00,000

Key Job Responsibilities:

  • Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies in consultation with functional team leads and project managers.

  • Perform centralized statistical monitoring and data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance.

  • Support monthly RBQM meetings by reviewing study data, documenting findings, action plans, and coordinating data cleaning activities to support study deliverables.

  • Evaluate the highest standards of data quality and integrity through proactive monitoring and timely interventions.

  • Collaborate closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies.

  • Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.

  • Monitor operational study metrics, including data entry trends, SDV backlog, site health trending, and proactively communicate issues to study team members to drive towards resolution and proactive remediation.

Job 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.

Key Qualifications:

  • Effective oral and written communication skills with the ability to communicate effectively with project team members.

  • Excellent organizational and time management skills.

  • Strong understanding of RBQM principles and methodologies.

  • Ability to work in a team or independently as required.

  • Proficiency in statistical analysis and data monitoring tools.

  • Detail-oriented with strong analytical and problem-solving skills.

Preferred Qualifications:

  • CRO experience as a Central Monitor.

Required Skills:

  • Statistical analysis and data monitoring.

  • Risk assessment and mitigation.

  • Report writing and presentation.

  • Collaboration and teamwork.

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