Suchismita Sikdar
Bangalore
Summary
Results-driven Clinical Project Coordinator with 2.8 years extensive experience at IQVIA, specializing in clinical project management, monitoring trials, and data reconciliation. Adept at ensuring data accuracy and quality in accordance with ICH-GCP guidelines and SOPs. Demonstrated expertise in coordinating study closeout activities, finalizing regulatory documents, and managing safety and non-safety reports. Proven ability to collaborate effectively with cross-functional teams to achieve seamless project execution and deliver highquality results.
Overview
3
3
years of professional experience
Work History
Lab Centralized Project Coordinator 1
IQVIA
02.2022 - 09.2024
- Clinical Project Management: Oversee the execution and interim monitoring of clinical trials, ensuring adherence to study protocols
- Manage and review clinical trial data, including queries and resolution, to maintain data integrity and compliance
- Data Reconciliation: Conduct thorough data reconciliation by comparing and cross-checking case report forms (CRFs) with other data sources
- Ensure accuracy and completeness of clinical trial data, addressing discrepancies promptly to uphold quality standards
- Reporting & Documentation: Generate and report study-related reports to stakeholders, providing insights and updates on trial progress
- Close out activities: Coordinate the closeout activities of clinical studies, including the finalization of documents in compliance with regulatory requirements and internal SOPs
- Safety Monitoring: Monitor safety and non-safety reports, liaising with respective laboratories to address and resolve any issues
- Ensure timely reporting of adverse events and other critical safety information in accordance with regulatory guidelines
- Cross-Functional Collaboration: Collaborate with cross-functional teams, including clinical operations, data management, and regulatory affairs, to facilitate smooth project execution and achieve project milestones
Education
POST GRADUATED - MICROBIOLOGY
St. Xavier's College
Kolkata01.2021
GRADUATED - Microbiology hons.
UNIVERSITY OF CALCUTTA
01.2019
12TH -
CBSE
01.2015
Skills
- Clinical Project Management
- Data Reconciliation & Quality Assurance
- Study Reporting & Documentation
- Safety Monitoring & Adverse Event Reporting
- Cross-Functional Team Collaboration
- Effective Communication & Problem-Solving
- Microsoft Office (Advanced excel, Power Point and Word)
- LEARNING’S-TMF AND CLINICAL DATA MANAGEMENT
Languages
English
Hindi
Hobbies and Interests
- Painting
- Sketching
- Digital art
Timeline
Lab Centralized Project Coordinator 1
IQVIA
02.2022 - 09.2024
POST GRADUATED - MICROBIOLOGY
St. Xavier's College
GRADUATED - Microbiology hons.
UNIVERSITY OF CALCUTTA
12TH -
CBSE