Summary
Overview
Work History
Education
Skills
Websites
Presentations And Awards
Publications
Languages
Locations
Personal Information
Languages Known
Certification
Timeline
Generic
Kaviya Manoharan

Kaviya Manoharan

Chennai

Summary

Accomplished and results-driven Clinical Research Professional with over six years of progressive experience in managing and coordinating all phases of clinical trials. Proven expertise in conducting pre-study site evaluations, regulatory documentation, interim monitoring, and study close-out visits in accordance with ICH-GCP and regulatory guidelines. Adept at delegating responsibilities, mentoring study staff, and ensuring high standards of data quality and protocol compliance.

Demonstrated ability to lead cross-functional teams, oversee complex projects, and foster strong collaborations with sponsors and stakeholders to ensure timely and successful study execution. Skilled in protocol development, site selection, patient recruitment, and data analysis, with a deep understanding of regulatory requirements and safety reporting (SAE). Recognized for strategic planning, operational efficiency, and a commitment to advancing clinical research that improves patient outcomes.

Overview

8
8
years of professional experience
15
15
Certification

Work History

Lecturer Cum Manager - Clinical Research

SRM Medical College Hospital and Research Centre
08.2023 - Current
  • Playing a dual role in imparting academic instruction in clinical research and managing ongoing clinical research projects at the Center for Clinical Pharmacology. The position requires a dynamic professional with strong teaching abilities, expertise in clinical trial operations, regulatory compliance, and research management.
  • Involved in departmental activities such as curriculum development, faculty meetings, advising sessions.
  • Deliver lectures and conduct tutorials/practicals for undergraduate (MBBS/Pharm D) and postgraduate students in Clinical Research, Pharmacology, and related fields.
  • Develop and update curriculum content in line with current industry and regulatory standards.
  • Mentor and guide students in research projects, dissertations, and internships.
  • Conduct workshops, seminars, and training programs on Good Clinical Practice (GCP), ethics, and clinical trial methodology.
  • Coordinate and manage all clinical research activities within the Centre, including investigator-initiated and sponsored trials.
  • Ensure adherence to ICMR, ICH-GCP, and CDSCO regulatory guidelines for clinical research.
  • Liaise with ethics committees, sponsors, CROs, and regulatory bodies as required.
  • Manage documentation, SOPs, and reporting processes related to clinical trials and academic research.
  • Assist in grant writing, project proposals, and research funding applications.
  • Oversee site initiation, recruitment, monitoring, data collection, and compliance for ongoing studies.
  • Supervise research assistants, coordinators, and administrative staff working on research projects.
  • Maintain research databases and contribute to publications and conference presentations.

ICMR Clinical Trials Site Manager

SRM Medical College Hospital and Research Centre
08.2023 - Current
  • The Clinical Trials Site Manager will oversee the day-to-day operations of clinical trials at the designated site, ensuring compliance with regulatory requirements, ethical standards, and ICMR guidelines. This role involves coordinating with investigators, research staff, sponsors, and regulatory authorities to ensure the successful and efficient conduct of trials.
  • Experienced in facing DCGI inspections, with a high success rate of the outcome.
  • Manage the entire project team to recruit over 80% of the participants in a shorter span of time, leading the top five high-recruiting sites among other sites nationally.
  • Accountable for the overall management of the site, from the study initiation to the study close-out activities.
  • Resolved conflicts between staff members in a timely manner.
  • Performed inspections of the facility on a regular basis to ensure security measures were followed.
  • Coordinate and manage clinical trial activities at the site in accordance with approved protocols, ICMR SOPs, site SOPs, GCP guidelines, and applicable regulatory requirements.
  • Serve as the primary point of contact between the trial site, sponsor, and ICMR central office.
  • Supervise site staff involved in the trial, including CRAs, research coordinators, and data entry operators.
  • Evaluated employee performance through regular reviews and feedback sessions.
  • Monitored worksite personnel to maintain high levels of quality and performance.
  • Reviewed project plans regularly to ensure deadlines are met on time.
  • Oversee subject recruitment, informed consent, enrollment, and retention activities.
  • Ensure proper documentation and maintenance of trial records, including source documents, CRFs, and regulatory binders.
  • Monitor compliance with protocol, and report deviations or adverse events as required.
  • Facilitate site audits and inspections by regulatory authorities and sponsors.
  • Manage site inventory including investigational products, study materials, and supplies.
  • Ensure timely data collection, data entry, and query resolution in collaboration with the data management team.
  • Prepared detailed progress reports for stakeholders, highlighting milestones and addressing potential issues.
  • Facilitated team meetings to discuss project status, challenges, and strategies for improvement.
  • Motivated and challenged staff to achieve results while offering developmental and educational opportunities.
  • Mediated conflicts between employees and facilitated effective resolutions to disputes.
  • Provided leadership, insight and mentoring to newly hired employees to supply knowledge of various company programs.
  • Analyzed reports to identify areas for improvement in performance or cost savings.
  • Prepared budgets and monitored expenses to stay within allocated limits.
  • Support budgeting, financial tracking, and reporting related to trial activities.
  • Organize training sessions for site staff on GCP, protocol requirements, and SOPs.

Clinical Research Associate

SRM DCP, SRM MCH & RC
Chennai
09.2019 - 09.2023
  • Led and monitored over 20 clinical trials (Phases I–III), ensuring adherence to ICH-GCP, Indian ethical guidelines, and protocol compliance from initiation to close-out.
  • Conducted site initiation, routine monitoring, and close-out visits, verifying data accuracy, regulatory documentation, and protocol adherence.
  • Maintained essential trial documents including source documentation, CRFs, study binders, and regulatory files, ensuring completeness and audit-readiness.
  • Collaborated with sponsors and CROs to resolve data queries, support audits, and ensure high-quality data collection and reporting.
  • Ensured proper storage of investigational product at investigator sites per GCP guidelines.
  • Prepared reports summarizing study progress and results for senior management review.
  • Screened and recruited eligible subjects, reviewed medical records, and coordinated with physicians and site staff as per protocol requirements.
  • Processed and shipped biological samples, ensuring compliance with study-specific handling and storage protocols.
  • Participated in investigator meetings and regulatory inspections, contributing to bioequivalence studies, and ensuring readiness for compliance checks.
  • Reviewed ISF, TMF, CRFs, and source data for consistency, accuracy, and compliance with SOPs, and regulatory standards.
  • Monitored safety events reported during the course of clinical trials in accordance with SOPs.
  • Supported regulatory submissions, including IRB/ERC packages, consent forms, and safety reporting, in alignment with local and federal guidelines.
  • Contributed to data analysis and subject management, including hiring, training, financial oversight, and ongoing participant support throughout the study duration.

Sr. Med Lab Tech

Biotech laboratories
04.2016 - 06.2016
  • Collected samples from various sources for analysis in accordance with established guidelines.
  • Conducted quality control testing on incoming materials to ensure accuracy of results.
  • Processed specimens following established protocols while adhering to strict safety standards.
  • Prepared reagents and solutions according to established protocols.
  • Managed inventory levels by ordering supplies and ensuring stock is available when needed.
  • Perform routine clinical chemistry analysis on human samples (blood, serum, plasma, urine) and generate accurate, timely diagnostic reports.
    • Analyze a broad spectrum of biochemical markers including cardiac markers, liver enzymes, renal function tests, and hematology parameters, with interpretation support for clinicians.
    • Conduct quality control checks on analyzers using Levey-Jennings chart rules, ensuring accuracy and reliability of laboratory results.
    • Operate and maintain laboratory analyzers such as Beckman Coulter AU 580, AU 600, and Advia Centaur, as well as semi-automated analyzers.
    • Perform blood grouping and Rh typing, ensuring precision in transfusion-related diagnostics.
    • Conduct ELISA testing with proficiency, handling human samples for a variety of immunodiagnostic applications.
    • Administer and interpret Mantoux tests for patients suspected of typhoid (note: usually used for TB—can clarify if needed), providing results to attending physicians for further treatment decisions.
    • Perform patient vital assessments, phlebotomy, and manage blood/sample collection, processing, labeling, and cold chain sample storage as per protocol.
    • Adhere strictly to laboratory safety, infection control policies, and biomedical waste disposal guidelines.
  • Implemented and adhered to laboratory safety protocols, including the proper disposal of hazardous materials.
  • Assisted in the troubleshooting and repair of laboratory equipment, minimizing downtime and ensuring continuous operation.
  • Assisted in the development and maintenance of laboratory SOPs, improving process efficiency and consistency.

Assistant Financial Accountant

Bismi Plastics
Chennai
01.2010 - 01.2011
  • Prepared monthly reconciliations of balance sheet accounts, including bank statements and intercompany transactions.
  • Provided support to external auditors during quarterly reviews and annual audits.
  • Performed general ledger account analysis, journal entries, and other accounting functions as needed.
  • Coded invoices to maintain organized and accurate records.
  • Mitigated losses and verified protocol compliance through skilled preparation and administration of clear and effective yearly budgets.
  • Collected and assembled financial data to analyze costs on year-to-year basis relative to fiscal planning and budgeting activities.Prepare detailed reports on audit findings.
  • Report to management about asset utilization and audit results, and recommend changes in operations and financial activities.
  • Collect and analyze data to detect deficient controls, duplicated effort, extravagance, fraud, or non-compliance with laws, regulations, and management policies.
  • Inspect account books and accounting systems for efficiency, effectiveness, and use of accepted accounting procedures to record transactions.
  • Confer with company officials about financial and regulatory matters.
  • Inspect cash on hand, notes receivable and payable, negotiable securities, and canceled checks to confirm records are accurate.
  • Examine records and interview workers to ensure recording of transactions and compliance with laws and regulations.
  • Prepare, examine, or analyze accounting records, financial statements, or other financial reports to assess accuracy, completeness, and conformance to reporting and procedural standards.
  • Review accounts for discrepancies and reconcile differences.
  • Establish tables of accounts and assign entries to proper accounts.
  • Examine inventory to verify journal and ledger entries.
  • Develop, implement, modify, and document recordkeeping and accounting systems, making use of current computer technology.
  • Decreased company costs through accurate financial modeling, which included debits and credits research, credit transactions, deposits and budgeting.

Education

M.Sc - Medical in Biochemistry

Sri Ramachandra Medical College & Research Institute (SRIHER)
Potheri
06.2019

B.Sc - Biochemistry

Ethiraj College For Women
Chennai
04.2016

Skills

  • Good Clinical Practice
  • Project management
  • Team leadership
  • Conflict resolution
  • Time management
  • Budget management
  • Quality assurance
  • Data analysis
  • Regulatory compliance
  • Stakeholder communication
  • Problem solving
  • Decision-making
  • Strategic planning
  • Analytical thinking

Presentations And Awards

  • Certified Faculty trained in developing Curriculum and Syllabus (FIT) from PURDUE University EPICS Program (as part of SRMIST-IEEE-EPICS)
  • Officially certified Professional and trained experience in electronic data capture systems for international and national clinical trials
  • Good Clinical Practice Certified professional – National Institute on Drug Abuse (NIDA), National Institutes of Health, Department of Health and Human Services.
  • Licensed Clinical Research Coordination- Level 1- RUTGERS HEALTH, Rutgers University’s hub for biomedical education, research, and health care, New Jersey.
  • Guest Lecture delivered on Fundamentals of Biostatistics and Hypothesis testing workshop using SPSS software on 03/11/23.
  • Presented Research Poster on 'Evaluation of Terminated Clinical Trials' at ICCPP 2023.
  • Presented Research Poster on 'Trends observed in the last five years' at ISCR 2023.
  • Represented India at the Volunteers in Research and Ethics Initiative in April 2023.
  • Research paper presented on 'Correlation of Novel Renal Biomarkers' at Research Day 2020, awarded SILVER MEDAL.
  • Research paper presented on 'Assessment of Hesitancy towards COVID-19 Vaccines' at Research Day 2022, awarded SILVER MEDAL.
  • Poster presented on 'Correlation of eGFR with Haematological Parameters' at ACBICON 2018, won BEST POSTER AWARD.
  • Awarded as University Second Topper during Post Graduate at Sri Ramachandra Medical College, SRIHER, Chennai.
  • Organizer of various International and national conferences, workshops, and CMEs.

Publications

  • COVID-19 Vaccine Hesitancy: What Have We Learnt?, GEORGE M, MANOHARAN K, JINSON J, PRIYADHARSHINI I, C CS, R BG, D AKA, D NK, S VPJ., Namik Kemal Med J., 12/01/24, 10.4274/nkmj.galenos.2024.50490
  • Evaluation of the current status of ethics committees in India, Panda, T., Lala, P.K., Manoharan, K., Jinson, J. and George, M., Perspectives in Clinical Research, 2024
  • Clinical trial trends over the last 5 years among the BRICS Nations., Manoharan, K., Jinson, J., Ramesh, K. and George, M., Perspectives in Clinical Research, 2024
  • Prediction of maternal and foetal outcomes among patients with preeclampsia, Samal, S., Manoharan, K., Jinson, J., George, M. and Rao, A.A., Placenta, 2023

Languages

English, Tamil, Hindi, Telugu, Malayalam, Turkish, German, Russian

Locations

SRM Medical College Hospital and Research Centre, Chennai, Tamil Nadu, 600089

Personal Information

  • Age: 30
  • Passport Number: Available and active
  • Marital Status: Single
  • Visa Status: Schengen Visa

Languages Known

Tamil
First Language
English
Proficient (C2)
C2
Telugu
Upper Intermediate (B2)
B2
Hindi
Upper Intermediate (B2)
B2
Malayalam
Intermediate (B1)
B1
Turkish
Intermediate (B1)
B1

Certification

- Certified Clinical Data Manager (CCDM)Certified Clinical Data Manager (CCDM)

Udemy Issued- May 2023

- Clinical Research Coordination Level 1Clinical Research Coordination Level 1

Rutgers HealthRutgers HealthIssued Feb 2023 · Expires Feb 2028

- Good Clinical PracticeGood Clinical Practice

The National Institute on Drug Abuse (NIDA)The National Institute on Drug Abuse (NIDA)Issued Apr 2022 · Expired Apr 2025

- Business Intelligence using Power BIBusiness Intelligence using Power BI

Skill NationSkill NationIssued Jul 2024

- Fundamentals of Agentic AI: Business Implications and Ethical InsightsFundamentals of Agentic AI: Business Implications and Ethical Insights

LinkedIn Learning CommunityLinkedIn Learning CommunityIssued May 2025

Timeline

Lecturer Cum Manager - Clinical Research

SRM Medical College Hospital and Research Centre
08.2023 - Current

ICMR Clinical Trials Site Manager

SRM Medical College Hospital and Research Centre
08.2023 - Current

Clinical Research Associate

SRM DCP, SRM MCH & RC
09.2019 - 09.2023

Sr. Med Lab Tech

Biotech laboratories
04.2016 - 06.2016

Assistant Financial Accountant

Bismi Plastics
01.2010 - 01.2011

M.Sc - Medical in Biochemistry

Sri Ramachandra Medical College & Research Institute (SRIHER)

B.Sc - Biochemistry

Ethiraj College For Women

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Kaviya Manoharan