KEERTHI MANNE
Virginia
Summary
Experienced healthcare data professional with over 14 years managing complex clinical and genomic datasets in pharmaceutical and regulated healthcare environments. Skilled in transforming large-scale data into structured formats and ensuring data quality through validation and governance. Managed global programs with over 30,000 subjects, integrating clinical and external data while resolving quality issues. Collaborated with cross-functional teams to produce analytical reports and actionable insights, utilizing AI-enabled workflows for improved data accuracy.
Overview
1
1
Certification
14
14
years of professional experience
Work History
Project Manager, Clinical Data Management / Data Acquisition Manager
SYMBIANCE / PTC THERAPEUTICS — FSP
08.2022 - Current
- Led healthcare data strategy and oversight for complex global clinical programs, focusing on data integration, external data, data quality, analytics, validation, governance, and analytical readiness.
- Oversee acquisition and integration of clinical, genomic/biomarker, laboratory, imaging, PK/PD, ECG, safety, diagnostic, wearable, digital health, medical device, eCOA/ePRO, and other third-party datasets.
- Develop approaches for transforming heterogeneous source data into consistent, structured, traceable, and analysis-ready information.
- Perform structured data review and analytical assessment to identify anomalies, inconsistencies, missing information, trends, discrepancies, and data-quality risks across multiple sources.
- Developed data-quality frameworks, review methodologies, validation activities, and quality metrics, enhancing the reliability and accuracy of complex healthcare datasets.
- Lead data mapping, transformation, reconciliation, validation, and transfer activities supporting integration of external and clinical data.
- Partnered with Clinical Operations, Medical Monitoring, Biostatistics, Statistical Programming, Engineering, Product, Design, laboratories, imaging providers, CROs, and technology vendors to investigate and resolve complex data issues, ensuring data integrity and reliability.
- Translate complex findings into clear analytical summaries, dashboards, reports, presentations, and recommendations for technical and non-technical stakeholders.
- Design and monitor KPI dashboards and analytical reports used by leadership to evaluate data quality, trends, risks, timelines, operational performance, and program readiness.
- Use SAS, SQL, Excel, Tableau, Spotfire, and Power BI to analyze data, identify trends, monitor quality, and communicate findings.
- Lead testing and validation of data workflows, including requirements review, test scenario development, UAT, QC, defect identification, issue tracking, and verification of expected outputs.
- Apply structured review methods to determine whether data-processing and analytical outputs are accurate, internally consistent, reproducible, complete, and aligned with defined requirements.
- Support AI-enabled and technology-driven data workflows through structured output review, quality assessment, validation, and human-in-the-loop evaluation approaches.
- Lead data governance activities covering data integrity, traceability, risk assessment, change control, CAPA, FMEA, root-cause analysis, and continuous improvement.
- Partner with Engineering, Product, and Design teams to translate healthcare data requirements into workflows, specifications, testing criteria, and quality expectations.
- Support regulated-data activities and inspections by maintaining traceability, validation evidence, reconciliation documentation, quality records, and defensible data workflows.
- Lead and mentor 8–10 data professionals, overseeing quality, workload prioritization, resource planning, analytical practices, and professional development.
- Managed an sFTP technology transition across internal teams and external vendors, validated workflows, and maintained continuity of critical data transfers.
Clinical Data Team Lead
PPD / THERMO FISHER SCIENTIFIC — Remote
05.2019 - 08.2022
- Led data strategy and quality oversight for complex global oncology programs involving large-scale clinical, genomic/biomarker, laboratory, imaging, PK/PD, ECG, safety, and electronic data sources.
- Evaluated heterogeneous datasets from multiple providers and systems to identify quality issues, inconsistencies, missing information, anomalies, trends, and integration risks.
- Managed external data integration, mapping, transformation, reconciliation, validation, and quality review, ensuring analysis-ready datasets for timely decision-making.
- Conducted structured data reviews and trend analysis to identify recurring patterns and potential quality risks.
- Developed data-quality metrics and reporting used to communicate data trends, risks, quality findings, and study readiness to Sponsors and cross-functional stakeholders.
- Worked closely with Clinical Operations, Medical Monitoring, Biostatistics, Statistical Programming, CROs, laboratories, imaging providers, and technology vendors to interpret and resolve complex data issues.
- Supported analytical readiness by ensuring integrated datasets were consistent, traceable, complete, and fit for statistical and scientific use.
- Developed and implemented standardized data processes, enhancing data consistency and facilitating efficient downstream analysis.
- Supported CDISC SDTM/AdaM standards and preparation of data for regulatory submissions and scientific analysis.
Clinical Data Manager
JOHNSON & JOHNSON — Remote
05.2017 - 05.2019
- Managed and analyzed clinical datasets supporting data integration, quality assessment, reconciliation, validation, and analytical readiness.
- Integrated vendor and laboratory data into clinical research environments, performing structured reconciliation and quality review to ensure data integrity.
- Reviewed clinical, laboratory, safety, and external datasets to identify discrepancies, missing information, inconsistencies, and data-quality trends.
- Generated data-quality metrics and operational reports, providing analytical summaries for study teams and stakeholders to facilitate informed decision-making.
- Collaborated with clinical operations, safety, laboratories, vendors, project management, and clinical sites to investigate and resolve data issues, enhancing overall data quality.
- Supported testing of clinical data systems, including requirements review, UAT, QC, issue identification, and verification of expected outputs.
- Supported quality documentation, data traceability, process improvements, and regulatory-quality deliverables.
- Rookie of the Year (2018) — recognized for top-quartile performance across the analyst cohort.
Clinical Data Manager
ICON — North Carolina
04.2015 - 03.2017
- Supported multiple global clinical programs involving data review, external data integration, reconciliation, validation, quality assessment, analytical readiness, and final data delivery.
- Reviewed clinical and external datasets, ensuring accuracy, completeness, consistency, and traceability to support data integrity.
- Supported data-quality metrics and trend analysis, investigating issues and facilitating cross-functional resolution to enhance data reliability.
- Coordinated with clinical operations, safety, laboratories, vendors, project management, and statistical teams to effectively resolve complex data issues.
Associate Clinical Data Manager
ICON — North Carolina
03.2013 - 03.2015
- Delivered clinical data, conducted data-quality reviews, and prepared analysis-ready data for stakeholder use.
- Facilitated clinical and external data review, reconciliation, quality control, validation, and data-transfer activities to ensure data integrity.
- Resolved data discrepancies by collaborating with cross-functional teams to investigate and implement solutions.
Education
Master of Science - Health Informatics & Technology
Sacred Heart University
USASkills
- Data management
- Clinical data
- Clinical trial design
- Diagnostic data
- Imaging analysis
- Pharmacokinetics
- Safety evaluation
- Regulatory compliance
- Health technologies
- Device integration
- Patient outcomes
- Healthcare data analysis
Personal Information
Title: HEALTHCARE DATA LEAD | CLINICAL & GENOMIC DATA | DATA ANALYTICS & AI EVALUATION
Certification
Certifications & Professional Training:
Certified Clinical Data Manager (CCDM) | Project Management Professional (PMP) | Medidata Rave Certified | CDISC SDTM / AdaM / CDASH | GCP / ICH | RECIST 1.1 / iRECIST | Veeva Vault CDMS Configuration & Validation
Accomplishments
- Managed complex healthcare datasets representing 30,000+ subjects across global clinical research programs and multiple therapeutic areas.
- Integrated and quality-checked clinical, genomics/biomarker, laboratory, imaging, PK/PD, ECG, safety, diagnostic, digital health, wearable, medical device, and third-party datasets.
- Reduced unresolved data issues by 45% through automated quality checks, structured data review, trend analysis, and targeted remediation.
- Standardized data mappings across 8 studies, reducing downstream analytical/statistical programming effort by 30% and improving consistency of analysis-ready data.
- Maintained a 99.5% clean-record rate through systematic data-quality monitoring, validation, reconciliation, and issue-resolution processes.
- Developed KPI and data-quality dashboards used by leadership to identify trends, risks, anomalies, operational issues, and program performance.
- Supported 4 successful regulatory audits/inspections through strong data traceability, validation, documentation, governance, and quality controls.
- Led technology-enabled data initiatives involving digital health technologies, wearables, decentralized/virtual trials, electronic outcomes, and participant-centric data collection.
- Managed and mentored 8–10 data professionals, establishing consistent review, quality, analytical, and delivery practices.
THERAPEUTIC & SCIENTIFIC DOMAIN EXPERIENCE
- Oncology & Hematology: Breast | Lung | Prostate | Thyroid | Uterine/Ovarian | Leukemia | Lymphoma | Multiple Myeloma | Immuno-Oncology
- Rare Disease & Neurology: Multiple Sclerosis | Parkinson's Disease | Alzheimer's Disease | Huntington's Disease
- Infectious Disease / Respiratory / Vaccines: HIV/AIDS | EBV | RSV | Influenza | Zika | COVID-19 / SARS-CoV-2 / Vaccine Development
- Additional: Cardiovascular | Hypertension | Chronic Kidney Disease | Ophthalmology | Age-Related Macular Degeneration | Glaucoma | Dry Eye Disease | Ulcerative Colitis | Rheumatoid Arthritis
REGULATORY, QUALITY & DATA GOVERNANCE
ICH-GCP | FDA | EMA | 21 CFR Part 11 | Data Governance | Data Integrity | Data Quality | Data Traceability | Risk Management | CAPA | FMEA | Root-Cause Analysis | Change Control | Validation | UAT/QC | Audit Readiness | Regulatory Inspection Readiness | SOPs | Regulated Healthcare Data
Timeline
Project Manager, Clinical Data Management / Data Acquisition Manager
SYMBIANCE / PTC THERAPEUTICS — FSP
08.2022 - Current
Clinical Data Team Lead
PPD / THERMO FISHER SCIENTIFIC — Remote
05.2019 - 08.2022
Clinical Data Manager
JOHNSON & JOHNSON — Remote
05.2017 - 05.2019
Clinical Data Manager
ICON — North Carolina
04.2015 - 03.2017
Associate Clinical Data Manager
ICON — North Carolina
03.2013 - 03.2015
Master of Science - Health Informatics & Technology
Sacred Heart University