Omega Christy

Clinical Data Management professional with 4.7 years of experience serving as the primary DM point of contact across complex international trials. Proven track record in leading end-to-end data management deliverables from data collection through database lock, coordinating SDTM-aligned data flows, and managing cross-functional stakeholder collaboration. Experienced in developing Data Management Plans, overseeing CRO/vendor oversight under FSO outsourcing models, and ensuring audit and inspection readiness in compliance with ICH GCP standards.

Adept at risk identification, proactive resolution, and mentoring peers, with a results-driven mindset, strong data integrity commitment, and an independent, accountability-focused approach.

Clinical Data Specialist - IQVIA

(2021-09)

• Lead data management trial teams as the primary DM point of contact, driving cross-functional collaboration with clinical operations, biostatistics, medical monitoring, and regulatory stakeholders.
• Managed comprehensive DM deliverables from data collection to database lock, including coordination of SDTM, ADaM, and TFL deliverables to support regulatory submissions.
• Developed and maintained Data Management Plans (DMPs), contributed protocol input to optimise trial design, and defined data collection strategies aligned with CDISC and regulatory standards.
• Oversaw DM risk management through RACT processes, proactive risk identification and resolution, ensuring data quality and integrity across all study phases.
• Provided CRO and vendor oversight within the FSO outsourcing model, ensuring timely and high-quality delivery of all data management commitments.
• Maintained trial-level audit and inspection readiness, ensuring compliance with ICH GCP guidelines and internal SOPs throughout the study lifecycle.
• Mentored junior team members, identified best practice opportunities, and actively contributed to knowledge-sharing forums based on subject matter expertise in CDM.
• Applied strong analytical and data literacy skills to review complex datasets, identify trends, and generate actionable insights to support study progress and data quality decisions.
• Managed multiple concurrent studies simultaneously, adapting to variable workloads with a systematic and organised project management approach across clinical trial settings.
• Performed in-depth clinical data review, edit check review, query management, and reconciliation activities to uphold data integrity throughout the trial lifecycle.
• Executed data review in alignment with the Data Management Plan, raising and tracking queries to resolve missing or discrepant data, ensuring completeness ahead of database lock.
• Generated, resolved, and tracked queries to address discrepant data identified during aggregate data review; implemented innovative solutions to streamline CDM workflows and reduce rework.

Master of Science - Biochemistry - Mount Carmel College (2021)

Bachelor of Science - Biotechnology, Biochemistry, Genetics - Seshadripuram First Grade College (2019)