CURRICULUM VITAE

Personal Information

Full Name: Parveen Thakran, Mr

Job Title: Assoc Centralized Monitor
Country of Residence: India
Mobile No- +919896522357
Email-ID- Parveenthakran7@gmail.com

Summary
I have 4.5 Years of experience in clinical research field. I have done MSc. in clinical research from Amity
university Gurgaon. As a centralized monitor, I support the site team, CRA team and clinical leads in trail
related tasks to enhance data integrity and make the process smoother and easier..

Formal Educational History

Last Date Institution Name, Education Area of Study Completion

Attended Country Level/Degree Status
05/2019 Amity University Master of Science Clinical Research Completed
Gurgaon, India
05/2017 Amity University Bachelor of Medical Lab Completed
Gurgaon, India Science Technology

Work Experience:-

Date of Employment: 07/2021 - Present

Job Title: Associate Central Monitor
Business Title: Central Monitor
Key Responsibilities: Attend study team meetings as needed or requested.
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.)
Contribute to developing the study specific analytics strategy and/or work on
developing advanced analytics.
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.

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Manage 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-labelling, 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).
In collaboration with data owners and functional managers, contribute to
development of data analysis methods and procedures for mining study data;
performing the trend analytics for their respective study(ies
Attend study team meetings as needed or requested.
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.)
Contribute to developing the study specific analytics strategy and/or work on
developing advanced analytics.
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.
Manage 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-labelling, 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).
In collaboration with data owners and functional managers, contribute to
development of data analysis methods and procedures for mining study data;
performing the trend analytics for their respective study(ies)
Participate in study team meetings/Project kick off meets and interaction with
cross functional staff to verify information and/or triage new data issues or

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prior identified action items

Escalate quality issues pertaining to site and/or subject to respective
stakeholder within the project team.
Perform Subject Level Data Review that require further investigation with the
clinical site to determine overall accuracy (inclusion & exclusion criteria/
IP/AE/ Labs/EOT/EOS/ End points/SAEs etc.) Review any other information
as necessary to determine overall readiness of the patient information for
next level review.
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 (eg.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 of 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
Attend Kick-Off meets, weekly team meets, and client meets, as per the
project specific needs.

Date of Employment: 06/2019 - 07/2021

Name of Employer: Fortis Hospitals Limited
Job Title: Senior Assistant & Research Coordinator
Key Responsibilities: Facilitates and coordinates the daily clinical trial activities and plays a critical
role in the conduct of the study.
Schedules study subject appointments and serves as the patient liaison to
the PI and other participating physicians.
Reviews and comprehends each assigned protocol including study
proceedings and timelines.
Working closely with the PI, CRC participates in an integral way in the
informed consent process by communicating clearly with potential study
subjects about protocol. Possesses a thorough knowledge of the informed
consent process as well as a thorough understanding of the study protocol in
order to be able to answer all questions pertaining to the study posed during
the informed consent process.
Coordinates approval of new study agreements and contracts.
Coordinates and attends sponsor Site Selection visits, Routine monitoring
visits, and study close out visits.
Completes case report forms. Extracts data from patient file (Source
documents) in a timely manner.
Responds to data clarification requests in a timely manner.

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May attend Investigator meetings requiring travel and report pertinent

information back to research team members.
Coordinates with PIs and department to help ensure that clinical research
and related activities are performed in accordance with protocol, SOP, GCP
and applicable regulatory requirement
Assists the PI in development of materials and tools necessary to
appropriately train individuals involved in the conduct of the study, like study
protocol requirements, schedule of visits, execution of research plan.
Maintains records and other documentation of training.
Maintains subject screening logs and protocol deviation logs.
Maintains a excel sheet, tracking updates to database of all subjects
enrolled on clinical trials.
Coordinates and facilitates monitoring and auditing visits. Notifies
appropriate institutional officials of external audits.
Collaborates with PI and institution to respond to any audit findings and
implement-approved recommendations.
Completes documentation on each study visit that is used to track all study
related activities so that time, effort and materials can be accounted for on a
monthly basis.
Ensures that all materials for each clinical trial protocol are available for
subject enrollment.
Works collaboratively with the other members of the clinical research team
and the clinical and administrative support teams to ensure protocols are
followed and that there is timely documentation and submission of study
data.
Performs specimen processing and shipment of biological specimen
duties.
Assists with development of study materials including but not limited to, the
informed consent document, case report forms (CRFs), enrollment logs, and
drug/device accountability logs.
Establishes and organizes study files, including but not limited to,
regulatory binders, study specific source documentation and other materials
as required.
Assists the Principal Investigator in submission of accurate and timely
closeout documents to applicable IRB/IEC and applicable regulatory
requirement.
Arranges secure storage of study documents that will be maintained
according to institutional policy or for the contracted length of time, whichever
is longer.
Promotes the ethical conduct of research by reporting good faith
suspicions of misconduct in research.

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Clinical Trial Experience

Therapeutic Experience

Therapeutic Area Years Experience (Roles)

Exp
Other 2.5
COVID-19 2.5 site coordinator and CM
Gastrointestinal 2.0
Crohn's Disease 2.0 Site Coordinator
Ulcerative Colitis 2.0 Site Coordinator
Hematology 2.0
Paroxysmal Nocturnl 2.0 Site Coordinator
Hemogluria
Neurology 2.0
Multiple Sclerosis 2.0 Site Coordinator
Rheumatology 2.0
Rheumatoid Arthritis 2.0 Site coordinator
Ophthalmology 2.5
Ocular Hypersensitive 2.0 Central Monitor
Neovascular 1.0 Central Monitor
Psychology 1.0
Anxiety disorder 1.0 Central Monitor

Language(s)

Language Speaking Reading Writing

English Fluent Fluent Fluent

Publications, Doctoral Thesis

• Parveen Thakran & Dr Pramod Singh Khatri, An Assessment Of Knowledge, Attitude, And
Perception Of Pharmacovigilance Among Healthcare Professionals British Journal of BioMedical
Research, (ISSN:2456-9739) 02 (05); 2018, Page 512-530. Cross Ref DOI:
https://doi.org/10.24942/bjbmr.2018.338
• Parveen Thakran Primary central nervous system lymphoma(PCNSL) British Journal of Bio-
Medical Research (ISSN No2456-9739), 1(04); 2017, Page 205209. .Cross RefDOI:
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https://doi.org/10.24942/bjbmr.2017.169
• Dr Pramod Singh Khatri and Parveen Thakran Paediatric Wilms Tumor: Contemporary Prognosis
and Future Reflections British Journal of Bio-Medical Research (ISSN No2456-9739), 1(05);
2017,Page 241246. .Cross Ref DOI: https://doi.org/10.24942/bjbmr.2017.167

Curriculum Vitae: Parveen Thakran

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