Clinical Data Specialist

7 days ago

India beBeeData Full time ₹ 9,00,000 - ₹ 12,00,000
Central Data Monitor

We are seeking a skilled Central Data Monitor to join our team. In this role, you will play a critical part in ensuring the integrity and quality of clinical trial data through centralized monitoring activities. You will be responsible for leading the development of Risk-Based Quality Management (RBQM) plans, conducting study risk assessments, identifying study Key Risk Indicators (KRIs), performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly RBQM meetings.

Key Responsibilities:

• Study Risk Assessment: 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 Monitoring: Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance.

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

• Data Quality Assurance: 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 and data cleaning for studies.

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

Required 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 2 years' experience in clinical monitoring, clinical trial management, or equivalent.

• Working knowledge of ICH GCP guidelines and the clinical development process.

Skills and Qualifications:

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

• Strong organizational and time management skills.

• Excellent written and spoken English, including strong grammar and scientific vocabulary skills.

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

• Strong understanding of RBQM principles and methodologies.

• Demonstrated ability to learn how to extract pertinent information from protocols, electronic study data systems, clinical systems, dashboards, and to leverage these data to assess risk.

• Proficiency in statistical analysis and data monitoring tools.

Preferred Qualifications:

• CRO experience as a Central Monitor.

Benefits:

This role offers a competitive salary and benefits package, as well as opportunities for professional growth and development.

Other Requirements:

Applicants must have excellent analytical and problem-solving skills, with the ability to work in a fast-paced environment and meet deadlines. They should also have a strong attention to detail and be able to maintain confidentiality when handling sensitive information.

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