Poushali Laskar
Bengaluru
Summary
Highly skilled Clinical Research Professional with 5.5+ years of experience overseeing clinical trials and managing project deliverables. Proven track record of efficiently streamlining processes for improved trial execution and data collection. Strong coordination, communication, and leadership skills ensure compliance with protocols and regulations. Actively seeking a role in clinical data management and analytics to drive business growth.
Overview
6
6
years of professional experience
Work History
Clinical Lab Project Set Up Coordinator
IQVIA Laboratories
Bengaluru
02.2023 - 05.2024
- Regularly assessed project files and discussed results with stakeholders
- Led database setup and validation efforts for sponsor-related trials
- Participated in various phases of both ongoing and initial trials
- Supported development of incoming setup team members.
- Oversaw clinical data platforms for Phase I-IV trials.
- Collaborated with clinical research teams to establish data management plans, ensuring protocol compliance.
- Adhered to established SOP regulations for clinical data systems.
- Monitored data quality, troubleshooted issues, and ensured the timely delivery of clinical trial data.
- Delivered time-sensitive projects within different time zones, stretching beyond work zones.
Senior Clinical Publishing Coordinator
Labcorp
Bengaluru
07.2022 - 12.2022
- Created templates and documents to streamline the publishing process.
- Created investigator manuals, maintained regulatory compliance and enhanced trial efficiency through clear documentation and updated protocols and helped in site Initiation Project Management.
- Assisted in study initiation.
- Implemented performance enhancement strategies, ensuring continuous improvement and adherence to quality standards across operations.
Clinical Project Coordinator
Labcorp
Bengaluru
09.2020 - 07.2022
- Developed and maintained project plans and timelines.
- Monitored progress of clinical trials and reported results to management.
- Participated in the design, implementation, and analysis of clinical studies.
- Responsible for study initiation and study conduct.
- Enhanced service delivery with strategic meeting materials
- Executed performance enhancement methods, maintaining consistent quality standards
- Managed site modification tasks and site initiation processes, ensuring timely completion and regulatory compliance.
- Oversaw quality assurance programs to enhance performance and consistently achieve superior care standards.
- Ensured timely resolutions by liaising frequently with global partners.
- Trained team members on-demand
QC Executive
Biocon Limited
Bengaluru
06.2018 - 11.2019
- Media Preparation: Preparation of various types of media required for daily analysis in the microbiological lab. pH Checking: pH of various media post sterilization.
- Autoclave Cycle Running: Various loads in horizontal autoclave, like HPHV, VLT, BOWIE DICK, Media loads, etc., Dry heat sterilization, and destruction cycles.
- Equipment Handling: Calibration of weighing balance, pH meter calibration, Monitoring of incubators.
- Reconciliation: Measures to avoid wreaking havoc on the efficiency, quality, and account of the stocks of the various incoming media.
- Growth Promotion Test: Performing GPT of the readymade media and daily prepared in-house media to check for media sustainability.
- Water Analysis: Water analysis of various grades of water has been performed, and results interpretation can be done.
- Protocol Study: Protocol for hold time study of horizontal autoclave.
- Sound knowledge of cGMP and GDP and have experience facing audits.
- Cooperated with engineering, manufacturing, and corporate accounting to verify adherence to quality standards.
- Collected production samples regularly and performed detailed quality inspections.
- Developed and implemented strategies for improving the efficiency, accuracy, and reliability of product quality control.
- Monitored production lines for consistent adherence to established quality assurance protocols.
- Have been a point of contact during audits (EMEA) of quality control processes and procedures to ensure compliance with company standards.
Education
Master of Science - Biotechnology
SRM University
Chennai, India01-2016
Bachelor of Science - Biotechnology
Dr. D.Y.Patil ACS College, Pune University
Pune, India01-2014
Skills
- Database Management
- Data Entry
- Project Management
- Project Support
- Project Coordination
- Presenting Ideas and Plans
- Process Improvement
- Project assistance
- Document Control
- Laboratory Information Management Systems
- Veeva Vault (Quality Docs)
- Microsoft PowerPoint, Excel, and Word
- Quality risk management
- Multitasking
- Regulatory Compliance
- Cross-Functional Team Collaboration
- GAMP5 Methodology Knowledge
Languages
Bengali
First Language
English
Advanced (C1)
C1
Hindi
Upper Intermediate (B2)
B2
Timeline
Clinical Lab Project Set Up Coordinator
IQVIA Laboratories
02.2023 - 05.2024
Senior Clinical Publishing Coordinator
Labcorp
07.2022 - 12.2022
Clinical Project Coordinator
Labcorp
09.2020 - 07.2022
QC Executive
Biocon Limited
06.2018 - 11.2019
Master of Science - Biotechnology
SRM University
Bachelor of Science - Biotechnology
Dr. D.Y.Patil ACS College, Pune University
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