Summary
Overview
Work History
Education
Skills
Languages
Licenses and Certifications
Software
Certification
Projects and Publications
Timeline
AdministrativeAssistant
Divya Shah

Divya Shah

Senior Centralized Monitor
Trivandrum

Summary

I am Dr. Divya Shah, a highly motivated and experienced clinical research professional with over 6 years of expertise in site activation, clinical trial management, and regulatory compliance. Proficient in risk-based monitoring and well-versed in ICH/GCP guidelines, I bring strong organizational skills, attention to detail, and excellent communication and interpersonal abilities to the table. A dedicated team player, I am equally adept at working independently. With a deep passion for clinical research and a commitment to delivering the highest quality care to patients, I am well-prepared to contribute to the advancement of medical research.

Summary:

  • Highly motivated and experienced clinical research professional with 6+ years of expertise in site activation, trial management, and regulatory compliance.
  • Proficient in risk-based monitoring and strong understanding of ICH/GCP guidelines.
  • Organized, detail-oriented, and possess excellent communication and interpersonal skills.
  • Demonstrated ability to work both independently and collaboratively within teams.
  • Doctor of Pharmacy degree from Sree Krishna College of Pharmacy and Research Center.
  • Previous experience includes roles as a Clinical Trial Assistant at Lambda Therapeutics Research Ltd. and Study Start-Up Associate at ICON Plc.
  • Currently working as a Centralized Monitor at IQVIA.
  • Responsible for activating trial sites, managing data collection systems, ensuring ICH/GCP compliance, conducting risk-based monitoring visits, and maintaining communication with sponsors and investigators.
  • Committed to making a significant impact on patients' lives and contributing to the advancement of medical research.

Overview

7
7
years of professional experience
10
10
years of post-secondary education
2
2
Certifications
1
1

License

Work History

Senior Centralized Monitor

IQVIA
05.2024 - Current
  • Currently functioning as the Centralized Monitoring Lead (rCML) for APAC, assisting the team with system access, training completion, supply requests, and site activation for enrollment. Previously worked in LATAM, and EMEA regions.
  • Oversee risk-based monitoring activities, including i-Site preparation compliance, site visit monitoring compliance, action item management, study-specific site follow-ups on data queries in EDC, vendor queries, and potential deviation management.
  • Oversee site management activities on assigned projects, ensuring the quality and integrity of studies in accordance with protocols, SOPs, regulations, and guidelines.
  • Mentor junior CMS staff, fostering a sense of ownership and collaboration within the team.
  • Serve as a Subject Matter Expert for the CMS department, delivering trainings, conducting periodic reviews of centralized monitoring trainings, and identifying team training needs.
  • Lead and manage a team of Central Monitors and Clinical Analyst Support to ensure efficient site management and monitoring.
  • Develop and maintain Clinical Operations Plans and support the creation of iSite Pack templates and other tools for DTE studies.
  • Collaborate with stakeholders to set up and activate DTE Alert/Triggers dashboards.
  • Ensure SSV and Monitoring Attributes are updated in QRPM and request site monitor resources for site selection visits.
  • Track site activation critical elements and keep Clinical Lead and Start-up Lead updated on the status before site initiation.
  • Verify training compliance and system access for site management teams during study start-up and initiations.
  • Coordinate site initiation activities and ensure all critical elements are resolved.
  • Conduct ongoing risk assessments through data trending and analytics, proposing mitigation actions promptly.
  • Manage DTE Alerts and study-specific triggers, reviewing status of action items, and ensuring timely closure.
  • Support CRA in managing quality issues and sample review of iSite Pack, action items, and site-level documents on TMF.
  • Review RM Dashboard to resolve resource assignment errors and other issues.
  • Manage resourcing and transition of study team members during study execution, providing training as needed.
  • Approve Investigator Payments and manage service requests from CCO staff.
  • Provide regular study updates to Clinical Leads.

Centralized Monitor

IQVIA
08.2021 - 05.2024
  • Manage assigned studies with minimal supervision
  • Contribute to the development and use of study management plans and/or DTE specific tools and templates and/or other study specific plans to evaluate the quality and integrity of the study
  • Support project management team to develop monitoring strategy including monitoring triggers/thresholds
  • Manage 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, provide Inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections
  • Identify the value adds from the medical review & remote monitoring in the study and provide the inputs to relevant stakeholders
  • Support CL to perform oversight on clinical deliverables on assigned projects as per the protocol, SOPs, respective regulation/guidelines, and project Clinical Operations Plan
  • Collaborate with and support project resources (CRAs/ CTAs/Centralized Monitoring team)
  • Perform the IP management for the assigned study to identify risk and proposed mitigation (including re-supply, re-labeling, Import/export licenses etc.)
  • Ensure complete and accurate documentation of all the study specific tools and templates and keep the project audit ready
  • Perform centralized monitoring activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs respective regulation and guidelines
  • Ensure accurate completion and maintenance of internal systems, databases, tracking tools/reports for the project specific information
  • Perform Management of triggers and preparation of I-site pack for respective sites and countries for assigned study(ies)
  • Participate in (study) team meetings/Project kick off meetings and interaction with cross functional staff to verify information and/or triage new data issues or prior identified action items
  • Escalate quality issues pertaining to site and/or subject to respective stakeholder within the project team
  • Perform the activities delegated and/or act as back up for/to relevant stakeholders within the project team
  • Conduct periodic review of site level KRIs and historic site performance according to Central Monitoring Plan
  • Early identification of site-level risk/issue(s) occurring during study conduct and responsible for identification of risk
  • Monitor site performance and make recommendations for timely corrective actions (e.g., Site Telephone Contact or Triggered Onsite Monitoring Visit)
  • Review the effectiveness of the recommended actions and take appropriate additional actions if no effect is observed
  • Work in accordance with the Study Central Monitoring Plan
  • Establish and maintain effective project/ site level communications with relevant stakeholders
  • Maintain relevant project documents
  • Project Oversight to site management activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs respective regulation and guidelines
  • Act as mentor for junior CMS staff and foster ownership and collaboration with the team
  • Contribute as Subject Matter Expert to support the CMS department in delivering training's, perform periodic review of Centralized monitoring trainings and/or identify the training needs of the team and provide inputs whenever required., CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines
  • Follow up with site for EC submission and approval
  • Primary responsibility of getting the Essential documents ready for IP release and site activation
  • Actively involved in EC submission and tracking of documents along with Study startup team for local ECs and Regulatory authority of India
  • Involved in Budget preparation and follow up with site team until finalization
  • Assist the clinical team in the preparation, handling, distribution, filing and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
  • Assist with periodic review of study files for accuracy and completeness
  • Assist Project Manager with preparation, handling and distribution of clinical trial supplies and maintenance of tracking information
  • Assist Project Manager in arranging Kick off meetings
  • Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow
  • Assist with the tracking and management of Protocol Deviation
  • Act as a central contact for the clinical team for designated project communications, correspondence, and associated documents
  • Update various study tracker assigned by Project Manager
  • Maintenance of trial related documents and files (TMF, SMF) within the facility
  • Liaising with other functional groups and providing updates to project manager
  • BA-BE Monitoring activity
  • Preparation of SAE dossier and Regulatory submission and of IMP Release Checklist and site initiation activities.

Study Start up Associate- I

ICON Plc
11.2018 - 08.2021
  • Performing high quality CDP reviews according to the process defined in SOP's for "Critical Document Collection, Critical Document Package (CDP) approval and IP release
  • Providing SSU Lead/Designee with the CDP requirement sheet to discuss with the Sponsor
  • Updating CDP requirement sheet during the start-up phase of studies in consultation with SSU Lead/Designee
  • Customizing final Critical document Package/IP Release Checklist and Global CDP review worksheet including any Sponsor, Country, and Study specific requirements
  • Completing CDP reviews within defined and agreed timelines of receipt by the CDP review team/Designee
  • Completing review of CDP documents alongside the supporting Critical Document Package/IP release Checklist to confirm all the CDP documents are complete, consistent, current and in accordance with ICH/GCP and all applicable regulations, laws, and other guidelines and ethical standards
  • Returning to CDP Submitter any documents identified as incomplete, not current, or inconsistent
  • Sign and date the “Approved By” section of the Critical Document Package/IP Release Checklist to confirm approval of CDPs which are complete, consistent, current, and in accordance with ICH/GCP and all applicable regulations, laws, and other guidelines and ethical standards
  • Entering details of CDP reviews into the CDP Approval Trackers at the completion of each review
  • Uploading approved CDPs to agreed electronic filing systems
  • Review 1572 revisions and supporting documents to confirm whether it is complete, consistent, current, and in accordance with ICH/GCP and all applicable regulations, laws, and other guidelines and ethical standards
  • Primary responsibility of getting the essential document filed in Sponsor eTMF.

Clinical Trial Assistant

Lambda Therapeutic Research Ltd.
12.2017 - 11.2018
  • Assist Project Manager and Clinical Research Associate (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
  • Follow up with site for EC submission and approval.
  • Primary responsibility of getting the Essential documents ready for IP release and site activation.
  • Actively involved in EC submission and tracking of documents along with Study startup team for local ECs and Regulatory authority of India.
  • Involved in Budget preparation and follow up with site team until finalization.
  • Assist the clinical team in the preparation, handling, distribution, filing and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
  • Assist with periodic review of study files for accuracy and completeness.
  • Assist Project Manager with preparation, handling and distribution of clinical trial supplies and maintenance of tracking information.
  • Assist Project Manager in arranging Kick off meetings.
  • Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
  • Assist with the tracking and management of Protocol Deviation.
  • Act as a central contact for the clinical team for designated project communications, correspondence, and associated documents.
  • Update various study tracker assigned by Project Manager.
  • Maintenance of trial related documents and files (TMF, SMF) within the facility.
  • Liaising with other functional groups and providing updates to project manager.
  • BA-BE Monitoring activity.
  • Preparation of SAE dossier and Regulatory submission and of IMP Release Checklist and site initiation activities.

Education

Doctor of Pharmacy (Pharm D) - Pharmaceutical Sciences

Sree Krishna College of Pharmacy And Research Center
Trivandrum
08.2011 - 07.2017

Internship - Pharmaceutical Sciences

Cosmopolitan Hospital
Trivandrum
08.2016 - 07.2017

Clerkship - Pharmaceutical Sciences

Cosmopolitan Hospital
Trivandrum
08.2015 - 07.2016

CBSE Higher Secondary Education -

School of The Good Shepherd
Trivandrum
07.2009 - 06.2011

Skills

Ability to multitask

Languages

English
Hindi
Malayalam
Marathi

Licenses and Certifications

Registered Pharmacist, Kerala: 60563, 2017


IQVIA GCP Certificate, 2022


Software

Oracle ACTIVATE

EDC: Medidata-RAVE

Microsoft Office Suite

IQVIA- CM Platform

Oracle- CTMS

Oracle Seibel

Micromedex

TMF- Wingspan, I-TMF and e-upload

Sponsor ETMF

HQ/CPST Dashboard

Certification

Accountability And Delivery ICON Inspire Award for Site activation in Malaysia

Projects and Publications

Evaluation of rationality of fixed dose combination (FDC) of antihypertensive drug in multispecialty tertiary care hospital in south India. 

Author(s): 

Neethu J, Shah Diva Rakesh, Aparna Vitus and Jinsha Jaffar. 

Journal Name: 

Asian Journal of Medical and Health Research (AJMHR) 2016; 1(6).
-

Assessment of Prescribing Pattern of Antihypertensive Fixed Dose Combinations.
Author(s): 

Aparna Vitus, Jinsha Jaffar, Shah Divya Rakesh, Neethu J. 

Journal Name: 

Journal of Advance Pharmaceutical Research. 2016, 7(3), 81-87.
-

A Study on Side effects of Fixed Dose Anti-Hypertensive Combinations. 

Author(s): 

Neethu J, Jinsha Jaffar, Aparna Vitus, Shah Divya Rakesh. 

Journal Name: 

Indian research Journal of  Pharmacy and Science; 2016: June 3(2) 697-705.
-

Pharmacist Role in Drug Efficacy and Safety Implementation of FDC; A Pilot Study.
Author(s): 

Neethu J, Aparna Vitus, Jinsha Jaffar, Shah Divya Rakesh. 

Journal Name: 

American Journal of PharmTech Research. 2016; 6(3) 517- 529.




Timeline

Senior Centralized Monitor

IQVIA
05.2024 - Current

Star Performer of the month

01-2024

SME for Clinical operation plan (COP)

06-2023

IQVIA Impact Award: Bronze

04-2023

Star Performer of the month

03-2023

IQVIA GCP Certificate

08-2022

IQVIA Impact Award: Spotlight

06-2022

Centralized Monitor

IQVIA
08.2021 - 05.2024

Accountability And Delivery ICON Inspire Award for Site activation

05-2021

Collaboration ICON Inspire Award for Great Teamwork and Strong Responsibility

04-2021

Accountability And Delivery ICON Inspire Award for bringing in May CDPs

06-2019

Accountability And Delivery ICON Inspire Award

03-2019

Accountability And Delivery ICON Inspire Award for Site activation in Malaysia

01-2019

Study Start up Associate- I

ICON Plc
11.2018 - 08.2021

Clinical Trial Assistant

Lambda Therapeutic Research Ltd.
12.2017 - 11.2018

Internship - Pharmaceutical Sciences

Cosmopolitan Hospital
08.2016 - 07.2017

Clerkship - Pharmaceutical Sciences

Cosmopolitan Hospital
08.2015 - 07.2016

Doctor of Pharmacy (Pharm D) - Pharmaceutical Sciences

Sree Krishna College of Pharmacy And Research Center
08.2011 - 07.2017

CBSE Higher Secondary Education -

School of The Good Shepherd
07.2009 - 06.2011

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