SHIVANI KHARE
Brampton
Summary
Dynamic Clinical Trial Professional with over 6 years of progressive experience in managing global and regional clinical trials, currently leading clinical operations at Novartis, Mumbai. Expertise includes vendor management, IRB submissions, regulatory compliance, TMF oversight, and patient-facing documentation, ensuring high-quality and compliant research outcomes. Proven ability to facilitate communication between clinical sites, regulatory bodies, and cross-functional teams while adhering to ICH-GCP standards. Skilled in monitoring and guiding CRA and CTA teams, developing research execution plans, and enhancing training programs to effectively address emerging challenges.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Clinical Trial Associate
NOVARTIS, Mumbai, India
11.2024 - Current
- Manage the collection, preparation, and adaptation of essential documents for IRB/EC submissions and regulatory authority approvals.
- Establish and maintain trial systems, facilitate vendor selection, manage Third-Party Risk Management (TPRM) processes, SIM entries, Investigator File (IF), and Trial Master File (TMF) management at country and site levels, ensuring compliance with regulatory and organizational standards.
- Oversee vendor onboarding processes, verify site readiness ('Green Light' verification), and coordinate closely with local Qualified Persons to ensure complete documentation for initial and subsequent drug releases.
- Prepare and manage translations of Informed Consent Forms (ICFs) and patient-facing materials, engaging vendors as necessary for linguistic accuracy and cultural relevance.
- Ensure completeness and accurate archival of trial-related documentation within CREDI/SUBWAY systems, supporting country-specific Study Start-Up (SSU) strategies in collaboration with SSU Leads and Managers to meet timelines and deliverables.
- Uphold compliance with financial guidelines, regulatory requirements (ICH/GCP, IRB/IEC, Health Authorities), and Novartis Standard Operating Procedures (SOPs), providing comprehensive logistical support to SSU CRAs, CRAs, Clinical Project Managers, and SSU Managers across all clinical trial phases.
- Implement innovative, efficient processes aligned with Novartis' strategic objectives to optimize trial outcomes and operational effectiveness.
Centralized Site Associate
IQVIA, Thane, India
07.2021 - 07.2024
- Spearheading as an in-house CRA and carrying out Data review, Site Management/Communication, Protocol Deviation Tracking, Wingspan (eTMF) document upload and query resolution on assigned projects.
- As Novella’s in-house expert handling patient enrolment, protocol compliance, study site staff issues, IRB and regulatory document & data status, and various site metrics.
- Coordinating with the field CRAs and performing daily site activities, including site training, vendor management, normal ranges management, extending assistance in resolving site queries, patient recruitment, retention management, study supplies management, and other activities for conducting the studies as per the study protocol, applicable regulations, guidelines, and sponsor requirements.
- Precisely reviewing the quality and integrity of patient data at assigned sites through the in-house (remote) review of electronic CRF data.
- Executing risk–based quality trial management and risk-based monitoring (RBM) tool preparation to identify, assess, control, communicate, and review study risk.
- Performing data surveillance at specified intervals and throughout the duration of the trial as per the study plan.
- Regularly conducting meetings with the sponsors on assigned studies and multiple functionalities as per the management’s request.
Clinical Research Executive
Asian Heart Institute & Research Center Pvt. Ltd., Mumbai, India
04.2019 - 06.2021
- Coordinated with the Principal Investigators, Institutional Board members, Sponsors/CROs and conducted multiple clinical research trials adhering to GCP guidelines and other applicable regulatory guidelines.
- Effectively recruited & selected patients for trials and trained the team on ongoing clinical trials.
- Regularly followed up with patients and ensured their quality of life and progress during & after the medications.
- Prepared documents in compliance with the applicable regulatory requirements, GCP guidelines, and ethical principles originated in the Declaration of Helsinki.
- Correlated with the Sponsors, Research Teams, Pharmacists, IRB, Finance and other departments involved in the research.
- Prevented any undue influence either by the investigator or the trial staff throughout the research.
- Thoroughly interpreted the patient details to subjects before the trial.
- Documented the dosage and therapy modifications of each trial subject.
- Corroborated the accuracy of source documents and regularly updated other trial-related records.
- Ensured the data reported on the CRF were in accordance with the source documents.
- Precisely reported each adverse event or serious adverse event to the Sponsor/CRO and notified the same to IRB.
Education
Master of Business Administration - Business Management
NMIMS University
08-2023
Post Graduate Diploma - Clinical Research
Clinomic Center For Clinical Research Pvt. Ltd.
05-2019
Bachelor of Science -
Rashtrasant Tukadoji Maharaj Nagpur University
06-2018
Skills
- Clinical Trials & Research Management
- Operations Management
- Research Planning & Execution
- ICH, GCP, & FDA Regulations
- Compliance Management
- Study Start-Up Activities
- Patient Monitoring
- CRA & CTA Team Management
- Subject Level Data Review
- Study Plans Development
- Impact/Risk Analysis
- Quality Assurance
- R&D Management
- Requirements Gathering
- Reporting & Documentation
- Database Management
- Team Building & Management
Accomplishments
Spotlight award and Ovation Award in Oncology projects
Certification
Good Clinical Practice (GCP) from Clinical Trial Network authorized by NIDA, NIH, and DHHS, 2019 & 2022
CLINICAL TRIAL CONTRIBUTION
- Trial Indication: Cardiovascular Disease, Therapeutic Area: Cardiology, Trial Phase: III, Designation: Central Monitor
- Trial Indication: Glioblastoma Multiforme, Therapeutic Area: Oncology, Trial Phase: III, Designation: Central Monitor
- Trial Indication: Partial Lipodystrophy, Therapeutic Area: Metabolic Disorder, Trial Phase: III, Designation: Central Monitor
- Trial Indication: Metastatic Breast Cancer (MBC), Therapeutic Area: Oncology, Trial Phase: I, Designation: Central Monitor
- Trial Indication: Lupus Nephritis, Therapeutic Area: Nephrology, Trial Phase: III, Designation: CTA
- Trial Indication: Multiple Sclerosis, Therapeutic Area: Neurology, Trial Phase: III, Designation: CTA
- Trial Indication: Coronary Artery Disease, Therapeutic Area: Cardiology, Trial Phase: III, Designation: CTA
- Trial Indication: Chronic Spontaneous Urticaria, Therapeutic Area: Dermatology, Trial Phase: III, Designation: CTA
- Trial Indication: Proliferative Diabetic Retinopathy, Therapeutic Area: Ophthalmology, Trial Phase: III, Designation: CTA
Timeline
Clinical Trial Associate
NOVARTIS, Mumbai, India
11.2024 - Current
Centralized Site Associate
IQVIA, Thane, India
07.2021 - 07.2024
Clinical Research Executive
Asian Heart Institute & Research Center Pvt. Ltd., Mumbai, India
04.2019 - 06.2021
Master of Business Administration - Business Management
NMIMS University
Post Graduate Diploma - Clinical Research
Clinomic Center For Clinical Research Pvt. Ltd.
Bachelor of Science -
Rashtrasant Tukadoji Maharaj Nagpur University