Summary
Work History
Education
Skills
Languages Known
Research Experience
Activities\ Awards
Conferences/ Workshops Participated
Declaration
Timeline
Generic

Navneetha B

Kotagiri

Summary

Dynamic professional seeking challenging opportunities to leverage skills for organizational success and personal growth. Committed to upholding and enhancing brand reputation while delivering results with integrity and dedication. Strong focus on collaboration and innovation drives the pursuit of excellence in every task. Eager to contribute to a team-oriented environment that values commitment and forward-thinking strategies.

Work History

Clinical Trial Administrator

NOVO NORDISK INDIA Private LTD. Bangalore
08.2023 - Current
  • Managed sponsor Trial Master File (TMF) activities, including document review, quality control, and upload into the VEEVA Clinical Trial Management System
  • Customized, translated, and verified country/site-specific Participant Information Sheets and Informed Consent Forms
  • Preparation of Contracts and agreements, obtaining necessary signatures and upload to COUPA.
  • Responsible for updating national clinical trial registers (e.g. CTRI) with new or updated study related information.
  • Prepared Site Initiation Visit (SIV) kits and ensured on-site presence during SIVs to support site readiness and compliance.
  • Preparation of clinical trial application dossier and dispatch for EC submissions
  • Tracking study specific events and/or documents, and maintenance appropriate logs
  • Coordination with CRAs to ensure CIOMS/SAE tracking tools are up to date for timely and accurate safety reporting to PIs, ECs
  • Processing invoice and tracking trial related payments (e.g. investigator fees and EC fees)
  • Attended a training visit to an investigator site to strengthen operational understanding of clinical trial processes.
  • Reviewed the Investigator Trial Master File (ITMF) to ensure compliance with documentation standards and regulatory requirements.
  • Assessed subject files for completeness, accuracy, and alignment with Good Clinical Practice (GCP) guidelines.
  • Evaluated Drug Accountability (DUN) records to verify proper tracking, storage, and reconciliation of investigational products

Additional responsibilities:

  • Global Directory Administrators: As gatekeeper of global directory records, to create and maintain organization s and locations, review selected persons record to avoid duplicate.
  • HCO clean-up initiative in India: It was focused on resolving duplicate and outdated organization records in CTMS (Clinical trial management system) ensuring accurate site and department details for clinical trials.

Clinical Research Coordinator

JSS Hospital, Mysuru
07.2022 - 04.2023
  • Maintaining documentation of Investigator site file
  • Collecting, labeling & centrifugation of blood and urine samples
  • Responsible for using electronic tool-BEMAKI database
  • Responsibility of follow up of the patients

Education

Master of Pharmacy - Pharmacy Practice

J.S.S College of Pharmacy
01.2023

Bachelor of Pharmacy - undefined

J.S.S College of Pharmacy
01.2021

12th Std, HSC - undefined

Kendriya Vidyalaya
01.2016

Skills

  • Proficient in managing documentation workflows
  • Cross-functional teamwork skills
  • Flexibility in acquiring new skills
  • Regulatory compliance and audit readiness
  • End-to-end project oversight
  • Ability to work efficiently both independently and as part of a multidisciplinary team
  • Monitoring visits

Languages Known

English
Bilingual or Proficient (C2)
Tamil
Advanced (C1)
Hindi
Advanced (C1)

Research Experience

  • Dissertation work carried out as part M. Pharmacy curriculum; project titled: “Association of COVID-19 vaccine and its adverse birth outcomes: A prospective observation study”
  • Cardiotoxicity induction by oral administration of doxorubicin in zebrafish (2020-2021).

Activities\ Awards

Participated and secured second prize in Essay writing held on 18th Sept 2021 during National Pharmacovigilance week organized by Regional Training Centre for south Zone- PvPI.

Conferences/ Workshops Participated

  • Participated as delegate and presented entitles “Assessment of self-Medication Practice among Pharmacy Students” as Oral Presentation in 25th APTICON-2022
  • Participates as delegate and presented an Oral Presentation on International Conference entitled “Toxicological study of Legal High Substances- Benzocaine and caffeine in Rodent Model” held at ALNOOR-AIMST University on 9th – 11th April 2021.

Declaration

I do hereby confirm that the above information given is true to the best of my knowledge and belief.

Timeline

Clinical Trial Administrator

NOVO NORDISK INDIA Private LTD. Bangalore
08.2023 - Current

Clinical Research Coordinator

JSS Hospital, Mysuru
07.2022 - 04.2023

Bachelor of Pharmacy - undefined

J.S.S College of Pharmacy

12th Std, HSC - undefined

Kendriya Vidyalaya

Master of Pharmacy - Pharmacy Practice

J.S.S College of Pharmacy
Navneetha B