Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Software
Timeline
Barista
Karunakara Manjunatha

Karunakara Manjunatha

Manager, Specimen Data And Systems
Hyderabad,TG

Summary

Seasoned professional with 15+ years of expertise in biospecimen management, clinical data operations, and quality assurance. Adept at ensuring data integrity and regulatory compliance while streamlining processes through vendor onboarding and workflow automation. Highly skilled in advanced analytics tools (Spotfire, Power BI, Tableau, SQL) and industry data standards (CDISC, SDTM). Recognized for mentoring high-performing teams, driving process optimization, and enhancing system usability to deliver cost-effective, compliant solutions within global, matrixed environments.

Overview

15
15
years of professional experience
3
3
Certifications
5
5
Languages

Work History

Manager, Specimen Data and Systems

Bristol-Myers Squibb Business Services India Pvt. Ltd
10.2025 - Current
  • Enhanced user satisfaction of the Specimen Tracking Tool, improving usability, and adoption.
  • Maintained data integrity and quality in the Specimen Management System through proactive monitoring, QC frameworks, and rapid issue resolution.
  • Optimized dictionaries, mapping files, and reference forms, reducing manual intervention by 40%.
  • Delivered custom dashboards and visualizations (Spotfire, Power BI, Tableau) for real-time insights and faster decisions.
  • Led vendor onboarding and data transfer specification development, cutting onboarding time by 30%.
  • Enhanced user satisfaction of the Specimen Tracking Tool, improving usability, and adoption.
  • Mentored junior team members for career advancement, fostering a pipeline of future leaders within the organization.

Manager, Biospecimen Lead

Bristol-Myers Squibb Business Services India Pvt. Ltd.
07.2024 - 09.2025
  • Managed the end-to-end biospecimen lifecycle across multiple protocols and vendors, ensuring reconciliation, compliance, and timely identification of issues.
  • Developed comprehensive onboarding guides and trained new associates, improving team efficiency and knowledge continuity.
  • Designed dashboards and trackers using Tableau, Power BI, Spotfire, and Excel to visualize KPIs and operational metrics.
  • Built ETL processes and optimized databases using SQL; ensured seamless data integration across systems.
  • Proposed and implemented innovative solutions for unmapped specimen handling and vendor data reconciliation, reducing the daily mapping workload.
  • Created proof-of-concept models for process improvements, many of which were adopted for long-term benefit.

Delivery lead- Data management

Labcorp Laboratories India Pvt. Ltd.
04.2020 - 07.2024
  • Acted as the primary liaison with global clients, aligning project goals and priorities to ensure successful delivery.
  • Implemented cost-saving measures through diligent budget oversight and negotiation of contracts with third-party vendors.
  • Managed vendor relationships, negotiating contracts to secure favorable terms that positively impacted the bottom line.
  • Led end-to-end clinical data management across multiple protocols, including study setup, conduct, and closeout.
  • Led and managed a team of data professionals, ensuring timely delivery of high-quality outputs across projects.
  • Mentored and developed direct reports, driving performance and career growth.
  • Directed vendor engagement and data acquisition, ensuring accurate, timely data ingestion, and issue resolution.
  • Implemented risk management strategies and advanced QC processes to maintain data integrity and compliance.
  • Developed data standards and governance frameworks (CDISC, SDTM), managing master data, and dictionaries.


Asst. Scientific Manager

Affigenix Biosolutions Pvt. Ltd.
06.2016 - 03.2020
  • Quality Assurance: Ensured regulatory compliance (NABL, ICH, FDA, EMEA) through rigorous data review and approvals.
  • Program Management: Managed alliances and vendor/CRO relationships, driving contracts, and project execution.
  • Project Leadership: Led facility expansion and commissioning, applying best project management practices.
  • Laboratory Expertise: Developed and validated ligand-binding assays, and immunogenicity tests across species.
  • Enhanced research efficiency by streamlining laboratory processes and implementing best practices.
  • Mentored junior scientists, offering guidance on experimental design, data analysis techniques, and manuscript preparation to enhance their career growth prospects.

Junior Scientist

Bioeneeds India Pvt. Ltd.
04.2014 - 06.2016
  • Performed method validation and sample analysis for large molecules using ligand binding assays.
  • Conducted batch release analysis for in-vitro potency assays ensuring product quality.
  • Produced and purified polyclonal antibodies, supporting research and development needs.Method validation and sample analysis of large molecules by ligand binding assay.
  • Batch release analysis of Invitro Potency assays.
  • Production and purification of polyclonal antibodies.

Senior research assistant

Clinigen International limited.
01.2011 - 04.2014
  • Managed biospecimen lifecycle and chain of custody for clinical studies, ensuring compliance with global regulatory standards.
  • Utilized Watson LIMS and BLIMS for accurate specimen tracking, storage, and retrieval, maintaining data integrity.
  • Developed and enforced SOPs for specimen handling and documentation, supporting audit readiness and regulatory compliance.

Junior Executive

Biocon limited.
07.2010 - 12.2010
  • Oversaw biospecimen management, including segregation, storage, and retrieval of biological samples under controlled conditions.
  • Maintained chain of custody documentation and resolved discrepancies in collaboration with study directors and investigators.
  • Ensured proper usage of ultra-low temperature freezers and other specialized equipment for sample integrity.

Education

Master of Science - Biotechnology

Kuvempu University
Karnataka, India
01.2014

Bachelor of Science - Biotechnology

Sahyadri science college
Karnataka, India
01.2010

Skills

Clinical trial Data Management

Certification

OECD - GLP

Accomplishments

  • Reduced vendor onboarding time by 30% by standardizing data transfer specifications and streamlining integration workflows.
  • Enhanced user adoption and satisfaction of the Specimen Tracking Tool through usability improvements and targeted training initiatives.
  • Delivered advanced analytics dashboards (Spotfire, Power BI, Tableau) enabling real-time insights and accelerating decision-making across global teams.
  • Labcorp Chairman’s Award 2023- For demonstrating significant contributions in delivering world-class clinical data compilation as delivery lead.
  • Lead in developing process for Critical Specimen monitoring in Labcorp.
  • Established vendor engagement and vendor quality metrics for data acquisition in Labcorp.
  • Awarded as Collaborator of the year from Labcorp GSS team.
  • Awarded for process excellence in Labcorp GSS.
  • Lead the team for NABL accreditation of laboratory at Affigenix Biosolutions private limited.
  • Lead project coordinator within a year of joining the company (Affigenix Biosolutions private limited).
  • Timely completion of multisite tech-transfers projects from R&D to various Manufacturing companies, query responses, etc.

Software

Tableau

Spotfire

PowerBI

Watson LIMS

SoftmaxPRO

Timeline

Manager, Specimen Data and Systems

Bristol-Myers Squibb Business Services India Pvt. Ltd
10.2025 - Current

Manager, Biospecimen Lead

Bristol-Myers Squibb Business Services India Pvt. Ltd.
07.2024 - 09.2025

Delivery lead- Data management

Labcorp Laboratories India Pvt. Ltd.
04.2020 - 07.2024

Asst. Scientific Manager

Affigenix Biosolutions Pvt. Ltd.
06.2016 - 03.2020

Junior Scientist

Bioeneeds India Pvt. Ltd.
04.2014 - 06.2016

Senior research assistant

Clinigen International limited.
01.2011 - 04.2014

Junior Executive

Biocon limited.
07.2010 - 12.2010

Bachelor of Science - Biotechnology

Sahyadri science college

Master of Science - Biotechnology

Kuvempu University
Karunakara ManjunathaManager, Specimen Data And Systems