Summary
Overview
Work History
Education
Skills
Languages
Certification
Hobbies and Interests
Timeline
Generic

Swati Pal

Bangalore

Summary

Clinical research professional with over almost 2.5 years of TMF operation experience in managing clinical trial documents of multiple studies. Detailed oriented problem-solver with exceptional organizational skills. Well- developed team building skills. Works well with clients and co-workers. Committed and reliable to making sure the job tasks are completed correctly while multi-tasking all daily operation tasks. Excellent knowledge of clinical trial documentations, CFR title 21, ICH-GCP, Regulatory guidelines, Trial Master File structure and Purpose.

Overview

5
5
years of professional experience
1
1
Certification

Work History

TMF Specialist I

ICON Plc
Bangalore
02.2022 - Current
  • Perform 100 percent QC process of documents for content and completeness check in Wingspan.
  • Follow all applicable departmental Standard Operating Procedure and work instruction.
  • Maintain project and technical documentation in an appropriate manner.
  • Manage study documents such as study level, country level and site level.
  • Work with FR Team to create the action Item.
  • Perform indexing for submitted document
  • Ensure timely escalation as needed.
  • Calculating Matrix for India forecast.
  • Work as part of ALC approve list change.
  • Follow the action owners for open eTMF Issues.
  • Review and respond to TMF content quality issue and identifies trends per study and across program.
  • Comply with metrics established for performance TMF reviews.
  • Manages the identification of operational and logistical issues and resolution related to the TMF.
  • Maintain an understanding of applicable regulatory requirements.
  • Attend internal or external study team meeting as needed.
  • Ensure overall client satisfaction for all studies.
  • Participates in business improvement initiative to drive quality,productivity and continuous improvement of business processes.
  • Perform other duties/activities as assigned by study management team.

Clinical Research Coordinator

Incred CR
Bangalore
08.2021 - 01.2022
  • Conduct site/trial feasibility to identify and select the right site and investigator for the study.
  • Ensure timely compilation of all essential documents assisting regulatory package preparation, timely submission and follow up with site EC to resolve any queries and obtain approvals.
  • Ensuring site setup according to protocol, review patient data base and pre-screening identify physician network.
  • Coordinate for Clinical Trial Supplies receipt, accountability and storage.
  • Prepare site team for study initiation visit and coordinate with monitor for the visit.
  • Assist in the process of administering the informed consent to the potential objects and discussing in detail the patient information.
  • Ensure that site documentation remains current, accurate and complete.
  • Coordinate for lab samples collection and logistic, review of lab reports and update PI.
  • Review and implement appropriate recruitment/referral activities for active enrolment at sites.
  • Ensure CRF completion and query resolution on specified timeline.
  • Ensure patients follow-up visit and visit compliance, manage patient related reimbursement; site related payment.
  • Drug receipt, accountability, storage, dispensing and related documentation.

Teacher

National Shiksha Niketan College
Lucknow
05.2019 - 05.2021
  • Educating students based on Ministry of Education curriculum guidelines.
  • Administering homework and assignments to gauge and enhance the students levels of understanding.
  • Preparing, administering, supervising, and grading examinations, quizzes, and other assignments.
  • Create and distribute progress reports to both students and parents.
  • Planning and organizing academic events and activities, both in and outside of school property.
  • Educating students on following a school’s moral codes.

Education

GCP Certification Course - Clinical Research

NIDA Clinical Trials Network
Bangalore, India
10-2021

Professional Certificatecourse in Advanced Clinical Research - Clinical Research

AM Services
Bangalore
01-2021

Master of Science - Microbiology

University of Lucknow
Lucknow, India
01-2018

Bachelor of Science - Botany, Zoology And Chemistry

University of Lucknow
Lucknow
01-2016

Skills

  • Innovative & Critical Thinking
  • Trail Master File (TMF)
  • Good Documentation Practice
  • Training and Development
  • eTMF SLA
  • Multitasking abilities
  • Organization and Time management
  • Teamwork and collaboration
  • Effective Communication

Languages

Hindi
First Language
English
Upper Intermediate (B2)
B2

Certification

  • Done 3-month dissertation in 2018 on “Evaluation of Pseudomonas Putida for drought stress amelioration in different cultivars of Chickpea” from CSIR-NBRI, Lucknow.
  • Completed Multicenter, Open label, balanced, randomized, single-dose, two treatment, single period, parallel bioequivalence study of Ferric Carboxymaltose solution for injection of Dr, Reddy’s LaboratoriesLtd. India.
  • Received second prize on Microbial Disease and Cure “3D-Model” organized on 30th Nov 2015 (B.Sc. III) from Navyug Kanya Maha vidyalaya.
  • Done 12-month training program in ADCA in 2018.

Hobbies and Interests

  • Watching movies
  • Travelling
  • Studying
  • Cooking

Timeline

TMF Specialist I

ICON Plc
02.2022 - Current

Clinical Research Coordinator

Incred CR
08.2021 - 01.2022

Teacher

National Shiksha Niketan College
05.2019 - 05.2021

GCP Certification Course - Clinical Research

NIDA Clinical Trials Network

Professional Certificatecourse in Advanced Clinical Research - Clinical Research

AM Services

Master of Science - Microbiology

University of Lucknow

Bachelor of Science - Botany, Zoology And Chemistry

University of Lucknow

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Swati Pal