Shalini Mathew

I am a detail-oriented and organized professional with a strong clinical data entry and management background. I have a keen eye for accuracy and a thorough understanding of maintaining high-quality data in clinical research. My experience includes inputting, verifying, and managing data in compliance with regulatory standards and study protocols.

I am proficient in using clinical data management systems (CDMS) and electronic data capture (EDC) platforms, ensuring the integrity and confidentiality of patient information. With excellent problem-solving skills and a commitment to precision, I thrive in roles where attention to detail and collaboration are critical to success.

I am passionate about contributing to impactful research that advances medical knowledge and improves patient outcomes.

Clinical Data Management Professional
IQVIA
 

• Data Quality Management: Ensured the accuracy, consistency, and integrity of clinical trial data by performing thorough data validation and query resolution.
• Database Design: Assisted in the creation and management of databases, including CRF design, database testing, and validation according to study protocols.
• Regulatory Compliance: Maintained adherence to regulatory standards such as ICH-GCP, FDA, and EMA guidelines throughout all data management processes.
• Collaboration: Partnered with cross-functional teams, including clinical research associates (CRAs) and statisticians, to facilitate seamless study execution and data delivery.
• Timely Delivery: Successfully met tight deadlines for data lock and database closure while maintaining high standards of quality.
• Tools & Systems: Proficient in using clinical data management systems such as Medidata RAVE, Oracle Clinical, and other EDC platforms.

Key Achievements:

• Contributed to the successful completion of multiple Phase I-IV clinical trials by managing and delivering high-quality datasets.
• Reduced query resolution time by 15% through process optimization and proactive communication with study teams.
• Recognized by supervisors for exceptional attention to detail and commitment to data quality standards.

MBA PROJECT MANAGEMENT WITH DISTINCTION