amruta nalkar
@amrutanalkar
Clinical research professional at MMSH Clinical Research reviewing protocols and resolving discrepancies, transitioning into clinical data management.
IndiaWhat I'm looking for
At MMSH Clinical Research Pvt. Ltd., I review Protocols, ICFs, Protocol Amendments, and Country Specific Supplements against client requirements and SOPs. This work has given me direct familiarity with study design and endpoints that shape downstream data collection and CRF design.
I check clinical documents for accuracy, consistency, and completeness, and resolve discrepancies with cross-functional teams. I also track issues to closure and mentor new team members on review procedures and quality requirements.
Earlier at MMSH Clinical Research Pvt. Ltd., I prepared and formatted clinical documents and supported QC of low-complexity data tables. At Aissel Technologies, I conducted healthcare and life sciences research, validating and analyzing information from scientific literature, clinical trial registries, and other sources.
I'm trained in clinical data management fundamentals, SQL, and Advanced Excel. I’m looking to bring my QC and discrepancy-resolution experience to clinical data cleaning, validation, and query management.
Experience
Work history, roles, and key accomplishments
Scientific Document Reviewer I
MMSH Clinical Research Pvt. Ltd.
Feb 2024 - Present (2 years 8 months)
Perform QC review of clinical documents including protocols, ICFs, and amendments against client requirements and SOPs. Collaborate with cross-functional teams to resolve discrepancies and mentor new team members.
Associate Scientific Document Reviewer
MMSH Clinical Research Pvt. Ltd.
Oct 2022 - Jan 2024 (1 year 3 months)
Conducted QC reviews of clinical documents for compliance with client specifications and quality standards. Verified content consistency and resolved documentation inconsistencies.
Research Associate
MMSH Clinical Research Pvt. Ltd.
Apr 2022 - Sep 2022 (5 months)
Prepared and formatted clinical documents using standardized templates and supported QC of clinical documents and low-complexity data tables.
Marketing Analyst
Aissel Technologies
Jul 2020 - Jan 2022 (1 year 6 months)
Conducted secondary research using scientific literature and clinical trial registries. Collected and analyzed scientific and market data, and identified Key Opinion Leaders.
Business Research Analyst
Aissel Technologies
Jul 2019 - Jun 2020 (11 months)
Conducted secondary research and data mining for healthcare and life sciences projects. Collected and validated information from multiple sources ensuring accuracy and completeness.
Education
Degrees, certifications, and relevant coursework
Bapuji Institute of Engineering and Technology
Bachelor of Engineering, Biotechnology
2015 - 2019
Pursued a Bachelor of Engineering in Biotechnology, gaining foundational knowledge in biotechnological principles and applications.
BCRI
Advanced Diploma, Clinical Research
Completed an Advanced Diploma in Clinical Research, covering clinical research methodologies and regulatory aspects.
Tech stack
Software and tools used professionally
Availability
Location
IndiaAuthorized to work in
Job categories
Skills
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