Summary
Overview
Work History
Education
Skills
Accomplishments
Software
Timeline
Generic

Devyani Goel

Clinical Research Professional
Meerut

Summary

Over ‘9’ years of experience working. Enthusiastic Clinical Research Professional eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Clear understanding of work and training in regulatory affairs. Motivated to learn, grow and excel in Clinical Research Industry.

Overview

10
10
years of professional experience
1
1
Language

Work History

CDD & T Specialist, Technical Document Operation Specialist

Icon GSS
Chennai
05.2017 - Current
  • Assist with redaction of documents for public disclosure and managed the entire redaction process from start to end
  • Communicating with reviewers
  • Track documents requiring redaction
  • Hands on experience with policy 43, Health Canada, CSR, PSUR, IB, Protocol.
  • Led projects and analyzed data to identify opportunities for improvement.
  • Used critical thinking to break down problems, evaluate solutions and make decisions.
  • Participated in continuous improvement by generating suggestions, engaging in problem-solving activities to support teamwork.
  • Created spreadsheets using Microsoft Excel for daily, weekly and monthly reporting.
  • Carried out day-day-day duties accurately and efficiently.
  • Identified issues, analyzed information and provided solutions to problems.
  • Oversaw daily operations to ensure high levels of productivity.
  • Resolved problems, improved operations and provided exceptional service.

Technical Document Operation Specialist

Icon GSS
Chennai
07.2014 - 04.2017
  • Perform system administration activities required to activate/initiate/closeout study sites or studies in Phase II to V clinical trials and manage the input of data into specific applications
  • Perform manual data entry in: CTMS, TMF, CRF Imaging and various departmental databases
  • Ensure consistent receipt, analysis, classification, registration and disposition/filing/retrieval of hardcopy and electronic clinical trial essential documents and other clinical trial related documents to allow for their consistent tracking, inspection and security
  • Screen and sort incoming paper and electronic mail
  • Date and time stamp cover sheet of incoming documents
  • Determine appropriate routing
  • Prepare outgoing mail and distribute
  • Coordinate communications regarding progress and completion of study documentation, package creation and data entry activities to the various functional areas as appropriate
  • Configure/ Create/ Monitor / Update Regulatory Packages
  • Monitor/track appropriate documentation to meet contracted and agreed upon SR timelines
  • Coordination of study-specific clinical templates needed for tracking purposes located in Administrative Binders that are distributed to the study sites
  • Maintain weekly document processing metrics/errors/returns/delays for department - excel spreadsheet

Clinical Research Coordinator

Apollo Hospitals Educational & Research Foundation
03.2012 - 06.2014
  • Implementation of the Trial Protocol at Site, Informed Consent Process, Subject Enrolment activities and complying with visit procedures
  • Continuous interactions with study subjects, Investigators and Monitors
  • Knowledge of Drug safety reporting procedures, various reporting forms and Pharmacovigilance guidelines
  • Capturing, recording and reporting of Adverse Events and Serious Adverse Events in accordance to the timelines
  • Clinical Trial Project management, Study Budgeting, SOPs preparation, Clinical Trial Protocol, Informed Consent Forms and CRF preparation
  • Coordinating with Institutional Ethics Committee for Study submission and Notifications Coordinate for Site Selection, Site Initiation, Interim Monitoring and Site Close Out activities.

Education

Bsc - Life Science

Chaudhary Charan Singh University

Msc - Biotechnology

Lovely Professional University

Advanced PG Diploma - Clinical Trial Management

Apollo Hospitals & Anna University

Professional Diploma - Pharmaceutical Regulatory Affairs

James Lind Institute

Skills

Attention to Detail

Problem-Solving

Organization and Time Management

Teamwork and Collaboration

Teambuilding

Planning and Coordination

Decision Making

Multitasking Abilities

Excellent Communication

MS Office

Interpersonal Communication

Accomplishments

  • Won Several awards for Partnership and collaboration with sponsors on different projects.
  • Understanding of Clinical Data Management process
  • Hands on experience of eCRFs – Oracle and Inform-Phase Forward, Open clinica
  • Data entries in CRFs, Validation, Data Clarification forms and Queries resolution
  • In depth knowledge about the Guidelines and Regulations in Clinical Research – ICH GCP, Schedule Y, ICMR Guidelines on Bioethics, FDA Code of Federal Regulations
  • Mentored team of 5 staff members.
  • Achieved 100% result by completing project with accuracy and efficiency.

Software

MS Office, Microsoft Excel

Timeline

CDD & T Specialist, Technical Document Operation Specialist

Icon GSS
05.2017 - Current

Technical Document Operation Specialist

Icon GSS
07.2014 - 04.2017

Clinical Research Coordinator

Apollo Hospitals Educational & Research Foundation
03.2012 - 06.2014

Bsc - Life Science

Chaudhary Charan Singh University

Msc - Biotechnology

Lovely Professional University

Advanced PG Diploma - Clinical Trial Management

Apollo Hospitals & Anna University

Professional Diploma - Pharmaceutical Regulatory Affairs

James Lind Institute

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Devyani GoelClinical Research Professional