Dixa Solanki
Bangalore
Summary
I am currently working as Vendor Qualification Associate for IQVIA. My responsibilities are to support global vendors and contribute to qualification/re-qualification cycle time improvement while maintaining high levels of quality to support clinical trial execution with strong analytical capability to structure data in most effective way. I have coordinated with study team members across multiple therapeutic areas including Diabetics, Atopic Dermatitis and Biomedicine. I have also communicated and coordinated with team members across various regions like Latin America, North America, Asia Pacific, and European Union. I can relate my skills and knowledge professionally along with the process of constant learning that results in growth and development which culminates me into giving my best to every task by optimizing the use of the resources provided.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Vendor Qualification Associate
IQVIA
Bangalore
05.2023 - Current
- Contributes to qualification/re-qualification cycle time improvement while maintaining high levels of quality to support clinical trial execution.
- Strong analytical capability to structure data in most effective way.
- Effective documentation of vendor related services.
Global Clinical Trial Assistant
IQVIA
11.2021 - 05.2023
- I have assisted the sGTM in various phases of the study such as planning, maintenance and close out activities
- In start-up phase, I have support the sGTM in creating study specific folders, preparing KA COMR, drafting the welcome email
- Tracking the subject, site and visit status and milestones in CTMS/ sCTMS
- Assisted the sGTM in preparing reports and trackers to track various metrics (electronic data capture report, action items, Protocol deviations etc.)
- I have also Performed access management for the study team (CRA, SRS etc.) along with this I have done Project trainings- compliance reports, inclusion, and withdrawal of eTrainings as notified by sGTMs
- And have also Supported sGTM in checking compliance for monitoring plans
- Supported the clinical project team by accurately updating and maintaining clinical systems within project timelines
- Preparing, handling, distributing, filing, and archiving of clinical documentation and reports as per the scope of work and standard operating procedures
- Assisted the sGTM in providing a periodic review of the prospective principal investigators to be selected for participation in the study
- To ensure that the CRA transition documentation is complete
- Assist with periodic review of study files for accuracy and completeness
- Perform close out activities for study in close out phase
- Perform administrative tasks to support team members with clinical trial execution as needed
- Perform eTMF tasks for each Milestones Triggers (Pre FPV, FPV-LPV, country CO and Study CO).
Clinical Data Analyst
CBCC-Global Research
05.2021 - 10.2021
- I have worked as Jr. Data Analyst in CBCC Global research for 5 months.
- I learned Central lab data reconciliation, Data entry, User Acceptance testing, CRF designing, Programming (Which was related to User acceptance testing).
- I have also designed rules before conducting UAT.
- During this period of 5 months, I have shown maximum compliance and have followed all company policies.
Education
Master of Science - Clinical Research
Indus University
Ahmedabad05.2021
B.Pharm - Pharmacy
Parul University
Vadodara04.2019
Skills
- Project Coordination
- Stakeholder management
- Support Services
- Organizational Skills
- Quality Assurance
- Records Management
- Documentation Requirements
- Trial Oversight
- Interpersonal Communication
- Records Management
- Documentation Requirements
- Trial Oversight
Languages
English
Hindi
Gujarati
Certification
- GCP Certification
- LEAN trainings
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
If you really look closely, most overnight successes took a long time.
Steve Jobs
Timeline
Vendor Qualification Associate
IQVIA
05.2023 - Current
Global Clinical Trial Assistant
IQVIA
11.2021 - 05.2023
Clinical Data Analyst
CBCC-Global Research
05.2021 - 10.2021
Master of Science - Clinical Research
Indus University
B.Pharm - Pharmacy
Parul University
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