Hi, I’m
RASIKA BHALERAO
Senior Record Management Specialist
Pune,Maharashtra
Overview
5
years of professional experience
Work History
Tata Consultancy Service
Senior Record Management Specialist
07.2020 - 06.2025
Job overview
- eTMF Lifecycle Management: Lead end-to-end operational delivery of clinical trial documentation from initial study setup through to final archival.
- Quality Control & Compliance: Perform detailed QC reviews of study protocols, Case Report Forms (CRFs), and clinical study reports to ensure accuracy and regulatory alignment.
- TMF Health Checks: Conduct comprehensive TMF health audits, identifying missing documentation and significantly improving inspection readiness for global audits.
- System Administration: Manage internal trackers, clinical databases, and project plans to monitor the real-time status of trial documents.
- Cross-Functional Collaboration: Facilitate global communications with Vendors, CROs, and Clinical Trial Managers (CTMs) to ensure on-time document processing.
- Process Improvement: Identify workflow bottlenecks and contribute to process enhancements to streamline electronic.
Education
A.I.S.S.M.S.College of PharmacyPune
M. Pharm
06-2019
University Overview
GPA: 66.56%
Smt.Kashibai Navale College of PharmacyPune
B.Pharm
06-2017
University Overview
GPA: 60%
R.R ShindeJunior College, Maharashtra State BoardPune
H.S.C
06-2012
University Overview
GPA: 53%
Sadhna GirlsbHigh SchoolHadapsar Pune
S.S.C
06-2010
University Overview
GPA: 68.80%
Skills
TMF Operations: Study Setup, Maintenance, and Archival
Regulatory Compliance: ICH-GCP Guidelines, Clinical Audit support, and TMF Health Checks
Systems & Tools: eTMF Platforms (Veeva Vault/ BIRDS, CTMS, and Standard Office Suites
Quality Management: QC Review, Document indexing, and ALCOA Principles
Stakeholder Management: Global communication with CROs, CTMs, and Vendors
Clinical Operations & Trial Oversight
Timeline
Senior Record Management Specialist
Tata Consultancy Service
07.2020 - 06.2025
A.I.S.S.M.S.College of Pharmacy
M. Pharm
Smt.Kashibai Navale College of Pharmacy
B.Pharm
R.R ShindeJunior College, Maharashtra State Board
H.S.C
Sadhna GirlsbHigh School
S.S.C
Summary
Versatile Clinical Research professional with 4.11 years of experience specializing in Electronic Trial Master File (eTMF) management and rigorous Quality Control (QC). Demonstrated expertise in maintaining document integrity across global clinical trials, ensuring inspection readiness, and collaborating with cross-functional teams to optimize TMF health.
Tools Software Proficiency
- Veeva Vault
- CTMS
- BIRDS