Business Process Lead
VINEETH B R
Tata Consultancy Services
Bengaluru,KA
Work Preference
Job Search Status:
Open to work
Work Type
Full Time
Location Preference
RemoteOn-SiteHybrid
Location:
Bengaluru, KA, India
Open to relocation:
No
Minimum Desired Compensation
₹85000/yr
Important To Me
Career advancementCompany CultureHealthcare benefitsWork-life balancePersonal development programs
2
Languages
1
Certification
5
Years of experience
Regulatory-focused professional with 5 years of experience preparing, standardizing, and quality-checking clinical documentation for regulatory submission. Hands-on with the documents that make up submission data packages (Subject CRF, aCRF, Sample CRF, Define.xml, cSDRG/SDRG) under CDISC/SDTM and ICH-GCP expectations. Proven in document control, version management, peer review, and query escalation within strict timelines. CBAP and Six Sigma certified, with an MBA in Healthcare Management and M.Pharm in Pharmaceutical Technology.
Work History
Business Process Lead
4 Years- Prepare regulatory-facing submission documents (Subject CRF, aCRF, Sample CRF, Define.xml, cSDRG/SDRG) to meet regulatory and CDISC formatting requirements.
- Standardize file naming conventions and folder structures across clinical trial documentation, improving consistency and audit-readiness for regulatory submission.
- Perform formatting, optimization, and quality control of submission documents within established timelines, maintaining high accuracy for regulatory deliverables.
- Conduct peer and QC reviews of completed documents, resolving discrepancies before final sign-off and reducing downstream rework.
- Escalate documentation queries to Points of Contact and propose resolution options, supporting faster query closure and continuous process improvement.
- Work with cross-functional clinical data teams to keep submission documentation aligned with ICH-GCP and regulatory requirements.
Business Analyst
1 Year- Analyzed operational datasets to identify process gaps and efficiency opportunities.
- Acted as liaison between clients and internal teams, turning data insights into actionable decisions.
Education
MBA - Healthcare Management
M.Pharm - Pharmaceutical Technology
B.Pharm
Skills
Regulatory Submissions Support
ESubmission Readiness
Regulatory Document QC & Peer Review
ICH-GCP Compliance
CDISC / SDTM Standards
Define & cSDRG
Document & Version Control
Regulatory Documentation Standards
Cross-Functional Coordination
Query Management
Audit Readiness
Process Improvement (Six Sigma)
SAS
SQL
JIRA
Websites
Certification
- CBAP (Certified Business Analysis Professional)
- Six Sigma
- JIRA
- SAS
- SQL
- Anthropic Academy — Claude & Generative AI certifications (2026), including Claude Cowork, MCP, and AI Fluency series
INTERNSHIPS & LANGUAGES
English
B2
Upper intermediate
Hindi
B2
Upper intermediate
INTERNSHIPS & LANGUAGES
Business Development Consultant, ImpactGuru (2020); SAS Analyst Trainee, Web Drills (2018); Hospital Intern, BH&RC (2019); Retail Store Intern, Janhavi Medicals (2019); Industrial Training, Micro Labs Ltd (2016).
Timeline
Business Process Lead
Tata Consultancy Services
10.2022 - CurrentRead More
Business Analyst
MySoftLabs
09.2021 - 09.2022Read More
RGUHS Bangalore
B.Pharm
Read More
NMIMS Mumbai
M.Pharm from Pharmaceutical Technology
Read More
NMIMS Mumbai
MBA from Healthcare Management
Read More