Inchara R
Mysuru
Summary
Looking forward to joining a company with a dynamic environment that will allow me to use my commitment and hard work to learn and acquire knowledge for the benefit of the organisation. I am committed to upholding the reputation of my employer and will approach my work with the utmost sincerity and dedication.
Overview
3
3
years of professional experience
Work History
Clinical Trial Administrator
NOVO NORDISK INDIA Private LTD. Bangalore
08.2023 - Current
- Organization: NOVO NORDISK INDIA Private LTD. Bangalore
- Department: Clinical Operations (Rare Diseases – Growth Hormone Disorder, Sickle Cell Disease, Haemophilia)
- Duration: From 01st August 2023 to till date
- Operational Responsibilities:
- Worked with Adjacent affiliates (Malaysia) along with India.
- Customization, translation and verification of country and site-specific Participant Information Sheet and Informed Consent Form Preparation.
- Translation and verification, wherever applicable of study documents and patient materials.
- Preparation of Contracts and agreements, obtaining necessary signatures and upload to electronic systems.
- Responsible for updating national clinical trial registers (e.g. CTRI/NMRR) with new or updated study related information.
- Preparation of clinical trial application dossier and dispatch for EC submissions
- Preparation of SIV kits and dispatch to sites as per the initiation plans.
- Maintenance of sponsor TMF, and review and upload of study documents to eTMF.
- Tracking study specific events and/or documents, and maintenance appropriate logs.
- Distribution of IB in controlled manner and maintenance of distribution log.
- Coordination with CRAs to ensure CIOMS/SAE tracking tools are up to date for timely and accurate safety reporting to PIs, ECs.
- Supporting in arranging local IM and other departmental meeting or related activities.
- Attend relevant departmental meetings and teleconferences, including preparation and distribution of minutes.
- Attending project meeting, taking minutes and acting items.
- Order and shipment of trial related supplies and/or documents as per CRA’s requests (e.g. Needles, TMD devices, diaries etc.).
- Managing shipment clearances (e.g. providing required documents for customs, technical write up communication with agents and query handling).
- Processing invoice and tracking trial related payments (e.g. investigator fees and EC fees).
- Procurement of materials from vendor (e.g. taking quotes, generating PO) & follow up till delivery to site/office.
- Processing of vendor invoices (reviewing, taking necessary approvals and submission to accounts).
- Preparation of sponsor TMF documents for term archival and dispatch to RMC.
- Acting as back-office contact person for clinical team in their absence.
- Additional Responsibilities: Took up initiatives/additional responsibilities such as
- Global Directory Administrators: As gatekeepers for creating sites, additional site locations, study personnel in CTMS study countries, study sites, and in the global directory, please note that only the CTAs will have access to create these at any phase of the trial.
- Local Document Releaser: The LDR role in document exchange system enables affiliates and Clinical Development Centres to control the timing of releasing Investigator’s Brochures (IBs) & statements of applicability to trial sites, in line with local regulatory approvals.
- HCO clean-up initiative in India: It was focused on resolving duplicate and outdated organisation records in CTMS (Clinical Trial Management System), ensuring accurate site and department details for clinical trials.
- Innovation and Process Alliance: I have also led this team which drives continuous improvement by implementing creative solutions and optimising operational workflows. Their collaborative approach ensures efficient processes & fosters a culture of innovation across the organisation. (ICF Customisation and tracking in CTMS and launch of document exchange system).
Internship
NOVO NORDISK INDIA Private LTD. Bangalore
03.2023 - 07.2023
- Organization: NOVO NORDISK INDIA Private LTD. Bangalore
- Department: Clinical Operations (Rare Diseases)
- Duration: From 21st March 2023 to 31st July 2023
Education
M.Sc. - Molecular Biology
Yuvaraja’s College, University of Mysore
01.2022
2nd PUC - undefined
Gopalaswamy Shishuvihara Independent Pre-University College
01.2017
Skills
- Demonstrates strong organisational abilities and meticulous attention to detail in managing trial logistics and handling documentation processes
- Facilitates effective cross-functional communication & coordinates seamlessly with stakeholders
- Exhibits a willingness and adaptability to continuously acquire new knowledge as needed
- Ensures adherence to regulatory requirements and maintains preparedness for audits
- Provides comprehensive support for trials and efficiently tracks progress toward key milestones
- Good communication, interpersonal and customer service skills
- Ability to multitask and deliver within agreed timelines
- Ability to work independently and in a team environment with patient-centred business approach
- Bookkeeping
Affiliations
Yuvaraja's College Club Member of the Antibiotic Stewardship and Prevention of Infection Communities (ASPIC) Club, 2020.
Languages Known
Kannada
English
Hindi
Awards
Best CTA Award – Rare Diseases (H2 2023), Best Impact CTA Award (H2 2024)
Publications
- A paper entitled "The autophagy-specific exocyst subcomplex contributes to phagophore assembly site integrity by promoting phagophore expansion", as first author.
- This paper was published on 07th October 2025 in PNAS publication.
Timeline
Clinical Trial Administrator
NOVO NORDISK INDIA Private LTD. Bangalore
08.2023 - Current
Internship
NOVO NORDISK INDIA Private LTD. Bangalore
03.2023 - 07.2023
2nd PUC - undefined
Gopalaswamy Shishuvihara Independent Pre-University College
M.Sc. - Molecular Biology
Yuvaraja’s College, University of Mysore
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