Jubeda Khatoon Borbhuyan
Bangalore
Summary
Experienced with training programs and hands-on tasks related to industry. Utilizes strong analytical and problem-solving skills to support team objectives. Knowledge of industry standards and ability to adapt to evolving environments.
Overview
9
9
years of professional experience
Work History
Global Site Activation Analyst
IQVIA
04.2022 - Current
- To initiate and coordinate activities in Site ID phase by collaborating with the site ID lead which include initial Kick Off Meeting, Site ID resource request, updating the GSID tracker
- To generate Preselection reports, ensure all sites are contacted within 24-48 hours of Site Promotion in CTMS, compliance check with CSA to ensure follow up occurs, provide summary to SAM/GSIDL and CTMS compliance check for all site statuses, providing Site ID updates to Sponsor team and responding to their queries as an when required
- Initiate and coordinate Start up activities liaising with country teams, strategy for RA/EC/LEC submission, submission and approval timelines as agreed with sponsor, and as per country guidelines
- Coordinate, Support/Lead studies in Maintenance phase like Protocol amendments, CTA amendments etc and provide updates to PL, and sponsor and maintain trackers updated
- Coordinate with CSA teams for timely Filing and Tracking in Central Trial Management system, Trial Master File, and Site Activation Workflow (Drug Dev Spark system) in all the phases i.e Site ID, Start Up, Maintenance and also steady state
- Experience with Advarra, WCG-IRB and CIRB portals
- Experience in working closely with cross functional and other supporting teams to achieve timely site activation and operational activities
- Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines
- Assist and oversee the country level teams to compile, prepare, submit and obtain approval of the submission documents to IRB/IEC/Third body/Regulatory Authority in accordance with local requirements
- Oversee the collection and tracking of all the necessary documents required and perform a quality review, formatting, and compilation of the final documents for effective and compliant site activation and maintenance
- Ensure that all assigned maintenance and Start-up activities are on track and in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines
- Proactively identifying and escalating to Site Activation Manager, any risk to meeting deliverables
- Notify the Site Activation Manager of hours identified as Out-of-Scope or over burn, and review of the reports
- Upload of documents to Wingspan, Qarchive, Veeva vault, Site Activation Workflow at Study Level, to support Global Site Activation Manager as applicable
- Perform tasks for Maintenance projects (eg IB submissions, CTA amendments etc)
- Coordinate with the country team members for the submissions/approvals to meet the timelines and develop a submission strategy and work with Site Activation Manager for the same
- Review EAC (Estimate at Completion) data for projects
- Provide updates for Sponsor calls
- Drive CTMS, Wingspan and Site Activation Workflow compliance
- Familiar with Jira board
ASSOCIATE (QA-MEDICAL AFFAIRS)
STRIDES ARCOLABS
04.2021 - 04.2022
- Preparation and review of Standard Operating Procedures (SOP)
- Clinical Protocols Review
- Review of ICF
- Review of CRF
- Patient data and Log forms before finalization
- Review of Clinical Study Reports
- Review of Bioanalytical Method validation reports and Bioanalytical Study Reports
- Review of Trial Master File
- Perform Vendor Audits along with Lead Auditor, preparation and review of Audit Reports and support Lead Auditor during audit
- Responsible to liaise with the relevant team for the completion of a Corrective/Preventive Action Plan (CAPA plan) and follow-up and timely close-out of CAPA
- Ensure control of all MA SOP related forms and formats via Electronic Document Management System
- Responsible for compliance review of system to ensure availability of clinical operations staff training records (CVs, JDs, training logs & records)
- Support identifying and suggesting gaps in the Medical affairs processes and ensure SOP compliance
- Verification of Rate Card Compliance
- Support and facilitate Vendor Qualification Audits and Change Controls
- Support to maintain the system for deviation identification, investigation, root cause analysis, CAPA, tracking, and close-out
- In addition, Ensure Compliance for Quality Events such as Change Controls and Deviation, Review and Approval of RCI documents
- KNOWLEDGE OF THE FOLLOWING ASPECTS-
- Quality Management System :Trackwise
- Electronic Document Management system : Evalgenesis
- ICH E3 Guidelines
SENIOR EXECUTIVE DATA REVIEWER
SYNGENE INTERNATIONAL LIMITED
05.2017 - 04.2021
- To ensure the processes are aligned with the standards of Quality Management System
- To ensure Any Time Audit Preparedness of the facility
- To investigate and resolve probable Data Integrity issues within shop floor
- Report findings on compliance and carry out why-why analysis
- Review clinical/bioanalytical data according to standardized procedures, SOPs, to identify incomplete, erroneous or implausible data
- Bioanalytical protocol review
- Generate, track and resolve observations identified during data review for generation of consistent, timely and accurate data
- Identifying minor, major and critical observations and suggesting CAPA
- To ensure Data Integrity is followed as per ALCOA principles
- Quality audits (daily and monthly)
- In process audits for method validation and study sample analysis
- Review and reconciliation of raw data for Method validation, Method Development and project documents
- Review of BA/BE reports, Method Validation Reports, protocols, and standard testing procedures as per SOPs and guidelines
- Review of Clinical shipment of samples and related clinical documents as per the Clinical Approved Protocol
- Review of calibration documents (HPLC, Mass Spectrometer, Deep Freezers, Pipettes) and received COAs of standards and chemical solvents
- Maintenance of Calibration and Preventive Maintenance schedule
- KNOWLEDGE OF THE FOLLOWING ASPECTS-
- DATA INTEGRITY(ALCOA+)
- ICH M10 GUIDELINES; EMA GUIDELINES
- ANVISA & HEALTH CANADA GUIDELINES FOR BA/BE STUDIES
- PHASES OF CLINICAL TRIALS
TRAINEE (6 MONTHS INTERNSHIP IN ANALYTICAL R AND D)
STRIDES SHASUN LIMITED
03.2016 - 09.2016
Education
Masters - Pharmaceutical Analysis
PES COLLEGE OF PHARMACY
01.2017
Bachelors - Pharmacy
PES COLLEGE OF PHARMACY
01.2015
AISSCE -
DELHI PUBLIC SCHOOL
DIGBOI, ASSAM01.2011
AISSE -
DELHI PUBLIC SCHOOL
DIGBOI, ASSAM01.2009
Skills
- MS office applications (excel, word, powerpoint)
- Time management
- Team collaboration
- Attention to detail
- Documentation and reporting
- Excellent communication
- Written communication
- Documentation skill
- Project Support
- Team member support
- Managerial and decision-making skills
Disclaimer
I hereby declare that the information furnished above is true to the best of my knowledge.
Personal Information
- Father's Name: Mr. Nurul Islam Borbhuyan
- Mother's Name: Mrs. Kulsoma Khatoon Borbhuyan
- Date of Birth: 04/22/93
- Gender: Female
- Nationality: Indian
- Marital Status: Single
Timeline
Global Site Activation Analyst
IQVIA
04.2022 - Current
ASSOCIATE (QA-MEDICAL AFFAIRS)
STRIDES ARCOLABS
04.2021 - 04.2022
SENIOR EXECUTIVE DATA REVIEWER
SYNGENE INTERNATIONAL LIMITED
05.2017 - 04.2021
TRAINEE (6 MONTHS INTERNSHIP IN ANALYTICAL R AND D)
STRIDES SHASUN LIMITED
03.2016 - 09.2016
Bachelors - Pharmacy
PES COLLEGE OF PHARMACY
AISSCE -
DELHI PUBLIC SCHOOL
AISSE -
DELHI PUBLIC SCHOOL
Masters - Pharmaceutical Analysis
PES COLLEGE OF PHARMACY
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