Prasad Tekawade
Pune
Summary
Detail-focused Medical Writer known for productivity and efficiency in task completion. Used client-based AI for reconciliation/leaning of data, which was highly appreciated by the client and was further utilized for the whole team for saving time with 100% accuracy. Possess specialized skills in scientific research, regulatory writing, and medical communication, which enable the crafting of clear, concise documents that meet industry standards. Excel in time management, critical thinking, and collaboration, ensuring successful project delivery within tight deadlines.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Medical Writer/Clinical Transparency Report
Tata Consultancy Services
Pune
06.2023 - Current
- Ensured compliance with 21 CFR Part 54 financial disclosure requirements by verifying and documenting financial interests of clinical investigators for regulatory submissions to the FDA.
- Coordinated financial disclosure reporting for clinical studies under FDA guidelines.
- Prepared financial disclosure documents for clinical investigators to meet FDA regulations.
- To ensure that clinical investigators' financial interests that could impact the reliability of data submitted to the FDA in a marketing application are identified and disclosed by the applicant.
- Ensure all reports are generated according to standard operating procedures and applicable guidance documents.
- Ensured clinical investigators' compliance with FDA regulations by managing the completion and submission of Form FDA 1572.
- Identified and drove areas of process improvement for partnership, focusing on quality, efficiency, and compliance.
Quality checks of the FIDS form, CV, and 1572 form are FDA-required documents. (21 CFR 312.53 (C)) - Identify gaps in existing processes, and streamline them to improve quality and reduce turnaround time.
Updating CTMS for study information, contact creation, and updates. Uploading documents in Veeva eTMF.
Generate and quality-check Clinical Trial Transparency (CCT) reports to ensure regulatory compliance and transparency in FDA documents. - Manage the Regulatory Document Tracker to monitor the status of compliance documents, ensuring timely submission, and adherence to regulatory requirements.
- Manage and review Financial Interest Disclosure Statement (FIDS) forms to ensure transparency and compliance with regulatory standards.
- Implemented tracking systems for financial disclosures in clinical trials, ensuring transparency and compliance with 21 CFR Part 54 throughout the project lifecycle.
Clinical Data Manager Traniee
Jehangir Center for Learning
Pune
01.2023 - 04.2023
- Read and understand the study. Required documents (Protocol, Edit Checks, Specification document, and eCRF, etc.).
- Read and get trained on all client-specific data management SOPs, guidelines, process maps, and tools.
- Review DVS, eCRF screens, and test scripts for edit/SAS checks, create test scripts for UAT and other activities as specified in RACI. Write/Update the Data Management plan for the study.
- Allocation of study activities to Data Managers on a daily basis. Tracking the work completion status allocated to the DM.
Education
Bachelor of Pharmacy -
Savitribai Phule Pune University
Pune07-2022
High School Diploma -
St.Patrick's High School
Pune06-2016
Skills
- Veeva Vault
- Electronic Trial Master File (eTMF)
- Customer Management Tool (CMT)
- Clinical Control Tower (CCT)
- Clinical Data Management System (CDMS)
- Regulatory compliance
- Clinical documentation
- Financial disclosure
- Data management
- Quality assurance
Accomplishments
- 100% target compliance
Certification
- Postgraduate Diploma in Clinical Research
- Postgraduate Diploma in Pharmacovigilance
- Post Graduate Diploma in Clinical Data Management
Timeline
Medical Writer/Clinical Transparency Report
Tata Consultancy Services
06.2023 - Current
Clinical Data Manager Traniee
Jehangir Center for Learning
01.2023 - 04.2023
Bachelor of Pharmacy -
Savitribai Phule Pune University
High School Diploma -
St.Patrick's High School
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