Anu Abraham
Tiruvallur
Summary
Results-driven Clinical Research professional with over 7 years in global clinical trial operations and Risk-Based Quality Management across Phase II–IV studies. Expertise in centralized monitoring, quality risk management, and proactive risk mitigation. Skilled in collaborating with global teams and stakeholders to uphold subject safety and data integrity, leading initiatives that enhance study quality and operational efficiency.
Overview
9
9
years of professional experience
Work History
Centralized Monitor
IQVIA RDS India Pvt Ltd
05.2025 - 07.2026
- Lead a team of 10 Centralized Monitors, overseeing centralized monitoring activities utilizing Risk-Based Quality Management (RBQM) Methodologies.
- Act as Centralized Monitor - Point of Contact (POC) for Phase II to Phase IV clinical trials supporting Global Study Leads in study execution, risk oversight and cross- functional collaboration across Asia-Pacific, EMEA, Latin America, USA/Canada regions.
- Delivered subject matter expertise on centralized monitoring methodologies and risk management to enhance study oversight strategies.
- Perform Key Risk Indicators (KRI) Review and Risk Signal Detection using Risk Identification Visualization Tool, identifying emerging site level risk through trend analysis and signal detection, Generation of the Risk Assessment Report and escalation of significant risk signals with Clinical Operational and Study Leadership for Timely Intervention.
- Conducted quality review of centralized monitoring deliverables, ensuring compliance with protocols, standards, and study-specific monitoring plans.
- Support audit readiness and audit preparation through quality oversight activities.
- Collaborate with Sponsor, Global Operational Team and Cross-Functional Teams to track study progress and operational challenges.
- Provide the study level risk trends, country updates and operational insights in the global study meetings contributing to study oversight activities.
- Conduct comprehensive review of Clinical Data, Protocol Deviation Trend, Adverse Event Trend, SAE Reconciliation, Enrollment Metrics.
- Coordinated with study leads to review and develop Study Quality Review Management Plans (SQRMP) and study-specific trial monitoring plans.
- Involved in the portfolio initiatives and executed the successful implementation of remote site close-out visits by the central monitoring team.
- Mentor and train new team members and support onboarding and process training initiatives.
Assoc. Centralized Monitor
IQVIS RDS India Pvt Ltd
07.2021 - 04.2025
- Executed centralized monitoring activities from site activation through site close-out according to the study-specific trial monitoring plan.
- Conducted remote review of clinical data to identify potential risks at site and subject level, ensuring proactive risk management.
- Supported the CtQ monitoring activities through continuous evaluation of protocol compliance , enrollment trends, adverse events etc.
- Executed root cause analysis on risk signals identified in Key Risk Indicator Review, enhancing understanding of risk factors and informing future monitoring strategies.
- Collaborated with CRAs on Site Risk Summary Reports to highlight potential site and subject-level risks during Local Study Team connects with Country Operational Leads, facilitating informed decision-making.
- Provided support as back-up Centralized Monitoring Lead for two global studies, ensuring continuity in monitoring activities.
- Acted as remote CRA for a Phase IV study and was involved in remote site contact, follow-up on EDC Metrics, Document Review, IMP reconciliation, IMP temperature deviation reporting, Trial Master File review, and protocol deviation reporting in CTMS.
- Conducted quality checks on site risk summary reports and delivered onboarding training for new team members, ensuring consistent team performance.
Clinical Research Associate
MV Hospital for Diabetes Pvt Ltd
12.2019 - 03.2021
- Coordinated clinical trial activities from start-up to close-out, ensuring smooth progression and adherence to timelines.
- Served as primary site contact for CRA monitoring activities, facilitating communication and support.
- Ensured compliance with ALCOA+ standards for source documentation, facilitated timely data entry in the EDC, and resolved queries efficiently.
- Maintained site ISF and facilitated submissions and notifications to the EC, contributing to regulatory compliance and site readiness.
Scientific Analyst
Molecular connections Pvt Ltd
07.2017 - 12.2018
- Conducted structured scientific literature analysis and data curation, improving research quality and accuracy for projects.
- Managed client expectations by providing comprehensive analyses and strategic communication, ensuring alignment with research goals.
Education
Master of Science - Biotechnology
Loyola College
Chennai, Tamil Nadu01-2017
Bachelor of Science - Biotechnology
Biotechnology
Trichy, Tamil Nadu01-2015
Skills
- Risk-Based Quality Management (RBQM) & Centralized Monitoring Leadership
- Global Clinical Trial Operations
- ICH-GCP ( E6 R2 & R3)
- Data review oversight
- Quality Review Management
- Risk indicator review
- Study Quality Risk Management Plan
- Protocol Compliance Monitoring
- Site Performance Review
- Audit readiness
- TMF management
- Metrics reporting
- CAPA Support
- Clinical trial support
- Team Leadership and Mentoring
- Collaborative teamwork
- Critical thinking
- Communication
- Time Management
- Improvement Initiatives
Languages
English
Proficient
C2
Malayalam
Proficient
C2
Tamil
Advanced
C1
Hindi
Upper Intermediate
B2
System & Softwares
- CTMS: Oracle Siebel & Veeva Vault
- eTMF: D2 & Veeva Vault
- Shared Investigator Platform (SIP)
- TIBCO Spotfre
- EDC: Rave, Clinion, Inform
- IRT: Signant Health, Almac, S-Clinica
- Risk Management: QuORUM
- Vendors: QMS Median, Y Prime, Neurostatus.net, AMBRA, TrialMax, Clario
- MS Office
Certificates & Honours
- Clinical Data Management Certification (2019) from Syncrop Pvt Ltd, Bengaluru, Karnataka
- IQVIA Ovations Award (2022) : Recognized for providing the study deliverables with quality.
- GCP (E6) R3 Certification (2025).
- IQVIA Collaboration Award (2025): Recognized for the Collaboration and partnership
Timeline
Centralized Monitor
IQVIA RDS India Pvt Ltd
05.2025 - 07.2026
Assoc. Centralized Monitor
IQVIS RDS India Pvt Ltd
07.2021 - 04.2025
Clinical Research Associate
MV Hospital for Diabetes Pvt Ltd
12.2019 - 03.2021
Scientific Analyst
Molecular connections Pvt Ltd
07.2017 - 12.2018
Master of Science - Biotechnology
Loyola College
Bachelor of Science - Biotechnology
Biotechnology