Ekta Singh
Bangalore
Summary
Detail-oriented Clinical Operations Professional with 10 years of experience supporting and managing global clinical trials across all phases I,II,III & IV. Demonstrated expertise in developing and reviewing essential study documentation in compliance with SOPs and ICH-GCP guidelines. Proven track record in coordinating cross-functional teams, vendor management, and financial oversight to ensure timely and budget-compliant execution of clinical studies. Adept at organizing study meetings, managing trial master file (TMF) documentation, supporting risk-based monitoring strategies, and handling clinical sample logistics.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Clinical Trial Support Manager
Sanofi
Hyderabad
03.2025 - Current
- Study Documentation Development & Support
Created and maintained core study documents including Study Risk Management Plans, Monitoring Plans, Communication Plans, and training materials.
Collaborated with study teams to prepare recruitment and retention plans, newsletters, and internal "Who’s Who" guides. Developed and implemented study plans to ensure the timely completion of research projects. - Study Document Review & Compliance
Reviewed protocols, amendments, work instructions, and eCRF guidelines for operational accuracy and SOP compliance.
Supported centralized monitoring strategies by contributing to plan design and documentation.
Ensured up-to-date and audit-ready TMF and SharePoint. - Followed standard operating procedures to perform quality control audit ofdocumentation repositories.
- Financial Oversight & Budget Management
Assisted study lead in budget forecasting and expenditure tracking.
Conducted quarterly reviews and collaborated with vendors for final budget reconciliation. - Meeting Coordination & Team Communication
Facilitated cross-functional study team meetings, COSCL reviews, and vendor calls.
Coordinated investigator and monitoring training sessions to align on protocols and expectations. - Vendor Oversight & Clinical Sample Coordination
Oversaw outsourced vendor activities, ensuring KPIs were met and deliverables aligned with timelines.
Managed clinical sample logistics in collaboration with translational medicine and lab operations. - Identified opportunities for process improvements within the department.
Assoc Lab Project Services Manager
IQVIA, India
Bangalore
04.2021 - 02.2025
- Client Relationship Management: Built and nurtured strong client relationships, effectively serving as a liaison between sponsors and internal project teams to ensure alignment and satisfaction.
- Meetings & Training Coordination: Organized and facilitated cross-functional and investigator meetings, documented meeting minutes, tracked follow-ups, and provided timely project status updates; participated in the planning and execution of training sessions.
- Audit & Inspection Support: Actively contributed to both internal and external audits and inspections, ensuring all study documentation and processes complied with regulatory standards.
- Safety & Regulatory Compliance: Maintained strict adherence to safety protocols, environmental regulations, and Good Clinical Practice (GCP) guidelines across all trial activities.
- Leadership & Team Development: Coached and mentored junior staff, assessed training needs, and supported professional growth and team capability building.
- Vendor Oversight: Managed vendor relationships to ensure the timely and efficient delivery of goods and services critical to study operations.
- Operational Problem Solving: Applied analytical thinking and strong problem-solving abilities to resolve operational issues and support project continuity.
- SOP Governance: Drafted and reviewed departmental Standard Operating Procedures (SOPs) as part of the SOP Management Team to maintain consistency and compliance.
- Document Management: Oversaw the preparation, archival, and retrieval of critical study documentation, including Trial Master Files (TMF), Study Master Files (SMF), Informed Consent Forms (ICFs), and screening reports.
- Contract & Legal Coordination: Led the development and negotiation of contracts and change orders; collaborated with legal teams to ensure regulatory compliance and risk mitigation.
- Financial Planning & Analysis: Developed study payment schedules, conducted detailed project financial analysis, and contributed to strategic budget planning and profitability optimization.
Project Manager Assistant
EUROFINS BIOPHARMA SERVICES
Bangalore
09.2018 - 04.2021
- Project Management Support: Served as backup Project Manager; actively participated in project kick-off and study monitoring meetings to support project continuity and milestone achievement.
- File & Documentation Management: Maintained and organized both electronic and paper study files; collated project tracking reports and ensured timely updates to all project documents.
- Order & Shipping Coordination: Managed re-supply orders and processed outbound and third-party specimen shipping requests to ensure uninterrupted study operations.
- Clinical Database Maintenance: Reviewed and completed database cleaning forms to implement necessary updates and corrections for data accuracy.
- Stakeholder Communication: Handled internal and external correspondence, ensuring timely and professional responses to emails and study-related queries.
- Conflict Resolution: Identified potential issues, negotiated solutions, and resolved conflicts across stakeholders to maintain project momentum and alignment.
- Team Direction & Task Delegation: Provided clear direction to internal functional teams, set deliverable expectations, and established deadlines to ensure accountability and timely outputs.
- Process Improvement: Documented lessons learned and contributed to continuous improvement initiatives to optimize future project execution and reduce operational risk
Site Service Specialist I & II
ICON CLINICAL RESEARCH I
Bangalore
06.2015 - 09.2018
- Compliance & Audit Readiness: Collaborated with Site and Principal Investigators, Project Managers, and Clinical Research Associates (CRAs) to ensure regulatory compliance and prepare for internal and external audits.
- Clinical Data Review: Conducted thorough data reviews of clinical studies within the laboratory, ensuring accuracy, consistency, and adherence to protocol requirements.
- Technical Support: Provided timely and effective technical support to Investigator Sites and CRAs, resolving study-related technical issues to maintain study integrity and timelines.
- Clinical Database Oversight: Reviewed and processed responses to Data Clarification Forms (DCFs); updated clinical databases to reflect accurate and current information.
- Site Communication: Notified clinical sites of abnormal test results and ensured appropriate follow-up in alignment with safety protocols.
- Data Quality & Completeness: Ensured completeness and consistency of clinical data under study protocols and Good Clinical Practice (GCP) standards.
Education
Bachelor of Science - Biotechnology
Bangalore University
Skills
- Global regulatory submissions and approvals
- Regulatory compliance and auditing
- project coordination and leadership,
- Risk mitigation and issue resolution
- Stakeholder management and communication,
- Data analytics and visualization,
- Cross-functional collaboration,
- Process optimization and efficiency improvements
- Regulatory strategy development
- Regulatory intelligence and continuous improvement
Certification
- Base SAS certified, 06/16
- Six Sigma Black Belt
- Zen & Art of Problem Solving
- Being Your Best
- Art of Virtual Collaboration
- Communicate Right
- Own Your Success
- Learning Clinic - Site Initiation
- Pursuing PMP
- Pursuing total quality management
- Pursuing ISO Lead Auditor 9001:2005
Languages
Hindi
First Language
English
Intermediate (B1)
B1
Timeline
Clinical Trial Support Manager
Sanofi
03.2025 - Current
Assoc Lab Project Services Manager
IQVIA, India
04.2021 - 02.2025
Project Manager Assistant
EUROFINS BIOPHARMA SERVICES
09.2018 - 04.2021
Site Service Specialist I & II
ICON CLINICAL RESEARCH I
06.2015 - 09.2018
Bachelor of Science - Biotechnology
Bangalore University
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