Siddhi Kadam
Clinical Data Manager
Mumbai
Summary
Results-driven Clinical Data Management (CDM) professional with over 12 years of experience in global pharmaceutical and biotechnology clinical trials. Expertise includes the entire data management lifecycle, such as protocol interpretation, EDC setup, data review, external data reconciliation, discrepancy management, and database lock activities. Proven leadership abilities are complemented by strong project management, people management, and vendor oversight skills. Recognized for implementing process improvements and automation initiatives, including Lean Six Sigma methodologies, significantly reducing manual efforts and standardizing workflows while fostering collaboration with cross-functional stakeholders including Clinical Operations, Biostatistics, and external vendors.
Overview
13
13
years of professional experience
5
5
Certifications
1
1
Language
Work History
General Manager, Clinical Data Management
Accenture Technology Solutions Pvt. Ltd.
11.2022 - Current
- Lead and mentor a team of Clinical Data Managers overseeing data collection, cleaning, validation, and reporting across global trials.
- Manage workload distribution, project milestones, and ensure timely database locks.
- Conduct regular team meetings, evaluations, and provide constructive feedback to improve performance.
- Drive knowledge-sharing sessions and training programs to upskill new joiners and junior staff.
- Collaborated with leadership in process standardization and global delivery models.
- Act as Subject Matter Expert (SME) for client applications and worked as Data Manager for RAVE EDC setup/conduct/closeout.
- Led external vendor reconciliation (Labs, PK, Pre-advance, biomarker, ECG, Imaging, IVRS, Drug Accountability, eCOA).
- Designed and implemented automation macros for reconciliation and SLA monitoring, saving 20–30% manual effort.
Database Developer (Medidata RAVE)
IQVIA RDS Pvt. Ltd.
02.2021 - 11.2022
- Designed and developed CRF screens, visit matrices, edit checks in Medidata RAVE from study build to go-live.
- Delivered SAS/DRPS/DPS edit check specifications (Phase I–III) including vendor data checks for reconciliation.
- Maintained and updated eCRFs and SAS specifications for protocol amendments and post-production changes.
- Ensured compliance with regulatory guidelines and supported database change control processes.
Lead Clinical Data Manager
Cognizant Technology Solutions Pvt. Ltd.
12.2012 - 01.2021
- Worked on end to end CDM process (Setup Conduct and Closeout)
- Reviewed study protocol, timelines, and project plans.
- Authored and validated Data Review Plans (DRPs), Data Quality Management Plans, Edit Check Specifications.
- Conducted UAT testing, bug resolution, and database go-live readiness.
- Oversaw SAE reconciliation, DQCC (Data Quality Consistency Checks), edit check listings, and vendor data reviews.
- Worked with vendors (Premier, Covance, ICON, Oracle, ERT) for timely data delivery and reconciliation.
- Prepared meeting minutes, study dashboards, and client decks for internal and external review.
- Completed final data review, reconciliation, and database lock. Ensured compliance with SOPs and regulatory guidelines during DB lock. Coordinated with Statistics team for datasets and lock approvals.
- Automated lab reconciliation, reducing manual checks from 75 to 30 (received LEAN Six Sigma Gold Certification).
- Suggested process changes to improve SLA adherence and error reduction.
- Prepared macros for SLA calculations and reconciliation tracking, reducing manual workload by ~30%.
- Appreciated by clients for proactive data quality improvements and protocol deviation detection.
Education
Master of Science - Biotechnology
University of Mumbai
04.2001 -
Bachelor of Science - Biotechnology
University of Mumbai
04.2001 -
Skills
Proficient in InForm and RAVE
Proficient in J-Review and Spotfire
Operations management
Customer relationship management
Team leadership
Project management
Quality management
Clinical data management
Electronic data capture
Data cleaning
Clinical trial monitoring
Database design
Data validation techniques
Certification
Certified Clinical Data Manager (CCDM) – Verified 2025-02
Disclaimer
I hereby declare that the above information is true to the best of my knowledge and I take full responsibility for its accuracy. Siddhi Kadam | Mumbai
Timeline
General Manager, Clinical Data Management
Accenture Technology Solutions Pvt. Ltd.
11.2022 - Current
Database Developer (Medidata RAVE)
IQVIA RDS Pvt. Ltd.
02.2021 - 11.2022
Lead Clinical Data Manager
Cognizant Technology Solutions Pvt. Ltd.
12.2012 - 01.2021
Master of Science - Biotechnology
University of Mumbai
04.2001 -
Bachelor of Science - Biotechnology
University of Mumbai
04.2001 -
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