Devyani Goel
Meerut
Summary
Enthusiastic Clinical Research Professional with over 11+ years of experience eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Clear understanding of work and training in transparency domain. Motivated to learn, grow, and excel in Clinical Research Industry.
Overview
12
12
years of professional experience
Work History
Clinical Trial Transparency Specialist II
MMSH
Bangalore
06.2022 - Current
- Provide high-quality deliverables in an efficient manner
- Maintain a strong understanding of regulations and guidance's as they pertain to transparency and ensure compliance with regulatory timelines
- Developing Project Management skills of focus and prioritization to prevent distracting
- Effectively communicate relevant project information to internal and external parties
- Excellent internal and external customer service, communication, leadership skills, and teamwork
- Follow processes related to service management as appropriate (e.g., strategy, design, transition, support, etc.)
- Contributes to the development and/or revision of internal policies and procedures impacting Transparency
- Assumes greater scope of responsibility while ensuring the opinions/contributions of others are considered and valued to facilitate achievement of team goals.
CDD & T Specialist
Icon GSS
Chennai
05.2017 - 06.2022
- 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 analysed 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, analysed 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 with 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
Professional Diploma - Pharmaceutical Regulatory Affairs
James Lind Institute
Bsc - Life Science
Chaudhary Charan Singh University - Meerut
Msc - Biotechnology
Lovely Professional University
Advanced PG Diploma - Clinical Trial Management
Skills
- Redaction and quality review for EMA Policy 0043, 0070, EU-CTIS and HC-PRCI
- Prepare Redaction Packages for Sponsors
- Quality Checks of CSR, Protocols, Synopsis, PSUR, AE Reports
- Handling redaction of documents for EU-Request for Information (RFI)
- Automated tool to process Anonymization/Redaction of clinical documents
- Perform UAT Testing
- Project Management
- Trainings sponsor teams on redaction concepts (Personal data and Commercially Confidential Information)
- Resource Allocation
- Process Improvement
Accomplishments
- Received appreciation from various clients
- Mentored team of 5 staff members.
- Achieved 100% result by completing project with accuracy and efficiency.
Personal Information
Title: Clinical Research Professional
Languages
- Hindi
- English
Timeline
Clinical Trial Transparency Specialist II
MMSH
06.2022 - Current
CDD & T Specialist
Icon GSS
05.2017 - 06.2022
Technical Document Operation Specialist
Icon GSS
07.2014 - 04.2017
Clinical Research Coordinator
Apollo Hospitals Educational & Research Foundation
03.2012 - 06.2014
Professional Diploma - Pharmaceutical Regulatory Affairs
James Lind Institute
Bsc - Life Science
Chaudhary Charan Singh University - Meerut
Msc - Biotechnology
Lovely Professional University
Advanced PG Diploma - Clinical Trial Management
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