Sneha T Catherine
Bangalore
Summary
A driven and talented professional with a good knowledge in clinical research, seeking a challenging position in a research oriented organization that offers a competitive environment and continuous exposure to progressive research knowledge to further my skills and career.
A dynamic, ambitious, highly motivated individual and quick learner with strong leadership skills, analytical mindset, systematic and detail oriented, excellent verbal and written communication, good time management, team player, stakeholder management, thorough knowledge of medical terminologies, ICH-GCP and drug development process, familiar with structure and contents of clinical study documents. Flexibility and resourcefulness in responding to job challenges at workplace.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Centralized Monitor
IQVIA
Bangalore
07.2019 - Current
- Contributed to the development and use of study management plans and DTE specific tools and templates and other study specific plans to evaluate the quality and integrity of the study.
- Understanding of study specific requirements and assisting the project management team with day-to-day monitoring of trials.
- Supported project management team to develop monitoring strategy including monitoring triggers/thresholds.
- Managed the operational insight of the assigned project(s) and complete the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.)
With guidance, provided Inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections . - Supported CL to perform oversight on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulation/guidelines and project Clinical Operations Plan.
- Performed the IP management for the assigned study to identify risk and proposed mitigation (including re-supply, re-labelling, Import/export licenses etc.).
Ensured complete and accurate documentation of all the study specific tools and templates and keep the project audit ready.
Performed centralized monitoring activities on assigned projects and evaluated the quality and integrity of the study as per the protocol, SOPs respective regulation and guidelines. - Performed Management of triggers and preparation of i-site pack for respective sites and countries for assigned study(ies).
In collaboration with data owners and functional managers, contributed to the development of data analysis methods and procedures for mining study data; performing the trend analytics for their respective study(ies). - Project Oversight to site management activities on assigned projects and evaluated the quality and integrity of the study as per the protocol, SOPs respective regulation and guidelines
- Proactively trained fellow members of the team/new hires and enabling them to acquaint to process and system with much ease, achieve team collaboration and best possible team outputs.
Centralized Monitoring Coordinator
IQVIA
Bangalore
08.2018 - 06.2019
- Performed assigned tasks to support team members with project execution (examples of such tasks include but not limited to running system reports, preparing and distributing status reports, creating and maintaining study documents, etc.)
- Interacted with sites/CRA and follow-up of missing data, pending queries, SDV backlog, visit schedule, PD, etc.
- Assisted in preparation of i-site pack for respective sites and countries for assigned studies.
- Performed the activities as per the task list delegated by Centralized Monitoring Specialist/Centralized Monitoring Lead.
- Assisted in updating and maintaining data in systems within project timelines and per project requirement.
- Established and maintained effective project/site communication.
- Created and maintained relevant project documents.
- Ensured accurate completion and maintenance of internal systems, databases, tracking tools and project plans.
- Acted as a backup for Central Monitors.
Clinical Analyst Support
IQVIA
Bangalore
06.2017 - 07.2018
- Assisted Central Monitor with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
- Assisted the clinical team in the preparation, handling, distribution, and filing of clinical documentation and reports according to the scope of work and standard operating procedures.
- Assisted with periodic review of study files for completeness.
- Assisted Central Monitor with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Acted as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
- Performed assigned administrative tasks to support team members with clinical trial execution within the Centralized Clinical Operations model.
Education
Master of Science - Microbiology
St. Joseph's College of Arts And Science
Bangalore, India05.2016
Bachelor of Science - Microbiology, Zoology & Chemistry
St. Joseph's College of Arts And Science
Bangalore, India05.2014
Skills
- MS Office
- Process improvement
- Business Objects/Intelligence
- Project Management
- Decision Making skills
- Mentoring
Accomplishments
IQVIA Awards :
- Ovation Award , 2021
- Spotlight Award, 2020
- Applause - June, 2019
- Applause - October, 2018
- Applause - April, 2018
- Applause - November, 2017
Certification
- The Principles of Genetic Engineering, 2013
- Fundamental GCP Accreditation Exam (English) 4.0 , 2020
- GCP Certification Exam , 2022
Languages
English
Tamil
Hindi
kannada
French
Additional Information
Dissertation
"Investigation on Anti-biofilm activity of Guava Leaf extract on biofilms formed by Salmonella Typhimurium & E.coli"
Indian Institute of Science (IISC)
Submitted in partial fulfillment of the requirements for the degree of Master of Science in Microbiology,
2016 under the supervision of Dr. Dipshikha Chakravortty , Department of Microbiology
Extracurricular Activities
- Organized UGC sponsored State Level Seminar ‘Kaleidoscope – Seeing the Unseen’ in St. Joseph’s
College (Autonomous) - Coordinated many technical and literary events throughout the college career such as 'Ferment'- Microbiology fest and 'Exodus'-Inter collegiate Gospel Fest.
- Participated and won in several quizzes and sports tournaments organized by different colleges in Bangalore.
- Part of College Hockey and Netball in PUC, Football and Throwball girls team in UG course and Throwball team in PG course.
- Represented St. Joseph College of Arts and Science Bangalore for Throwball –
District - level tournament at Bangalore,Karnataka., 2013 - Represented Jyoti Nivas College for Hockey and won Runners up – District- level
tournament at Bangalore,Karnataka., 2009 and 2010 - Represented Bangalore for netball – State- level tournament at
Davengere, Karnataka., 2009
Other Interests
Sketching, baking, Dance and Sports - Throwball, Chess and Football.
Timeline
Centralized Monitor
IQVIA
07.2019 - Current
Centralized Monitoring Coordinator
IQVIA
08.2018 - 06.2019
Clinical Analyst Support
IQVIA
06.2017 - 07.2018
Master of Science - Microbiology
St. Joseph's College of Arts And Science
Bachelor of Science - Microbiology, Zoology & Chemistry
St. Joseph's College of Arts And Science
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