Tushar Ganguli
Principal Clinical Data Manager - Data Management Lead | SME | Clinical Research professional, 12+ years exp. in Clinical Data Management
- Role
- Principal Clinical Data Associate at Advanced Clinical
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Tushar Ganguli
12+ years of full-fledged lead experience in varied clinical data management (CDM) processes in clinical trials that fall under therapeutic areas like oncology, immuno-oncology, infectious diseases, endocrinology, respiratory, neuroscience, cardiology, and urology, and working with varied electronic clinical trial databases (EDCs) like Veeva EDC, Merative Zelta, Oracle Health Sciences InForm, and Medidata RAVE. Demonstrated leadership in working with CDM cross-functional teams like the direct sponsor PoC (global data managers/data quality reviewers), clinical data reviewers, vendor reconciliation leads, clinical database programmers, SAS programmers, SDTM/ADaM programmers, R programmers, medical data reviewers, clinical study project managers, medical coders, clinical research associates, clinical research coordinators, global study asset managers, clinical trial investigators, etc.Participating in varied meetings like the SMT and hosting direct 1:1s with the client PoC to demonstrate overall study health, providing study statuses, and organizing training sessions for the wider team. Attending online screen review meetings, pre-clean file and clean file meetings, and attending recurring internal cross-functional and resourcing and budgeting meetings.Proven expertise across the clinical trial startup stage, such as reviewing protocol; developing/reviewing data management plans (DMP) and all study-specific documents associated with the DMP; data transfer agreements (DTAs); electronic case report forms (eCRFs); validation and UAT of eCRFs; edit checks; SAS backend checks/listings and custom reports; and handling of unblinded data in clinical trials.Led study conduct activities like query management, local lab data entry of lab normal ranges (LNRs), SAS/manual listings review, SAE reconciliation, reconciliation of vendor file with or without results, and also assisted extensively in eCRF migration-related tasks. Relevant expertise in database lock/trial close-out activities, like study documentation in the trial master file (eTMF), creation of acknowledgement of receipt letters (AORs) and flash-drive shipment letters, access revocation and/or updates, study data archival per database lock checklist, etc. Strong experience in quality control (QC) of data management tasks performed by subordinate data managers, as well as handling sponsor and regulatory audits related to CDM processes in clinical trials. Ensuring CDASH and CDISC standards are met for designing and populating eCRFs and submitting clinical trial data to the FDA.
Experience
Principal Clinical Data Associate
Jun 2025 — Present · IN
Oversee tasks executed by the senior clinical data associate (senior CDA) and clinical data associate (CDA), like the creation of critical startup documents, such as data management plans (DMP), edit check specifications (ECS), SAS checks/listings, and electronic case report forms (eCRFs), custom reports, and external vendor data reconciliation specifications. Oversee user acceptance testing (UAT) and support electronic data capture (EDC) module integrations. Conduct training of subordinate data managers to explain the process of eCRF migration, local and central labs, data management plan, data quality review plan, eCRF completion guidelines, protocol deviation review document, unblinded and blinded data review guidelines, and data transfer specifications. Performing serious adverse event (SAE) and vendor reconciliation, local lab data entry of lab normal ranges (LNRs), and ensuring seamless data resolution processes. Assisting in study setup and eCRF migration-related tasks. Identify data trends and implement corrective actions collaboratively. Actively participate in study-level audits and ensure audit readiness as necessary. Perform user account management, master user list reconciliation, and monitoring of EDC archival tasks. Act as a subject matter expert (SME) for an activity within the data management portfolio. Review quality control processes and study and/or molecule-level metrics reporting to ensure data integrity. Provide guidance on departmental and company procedures and conduct. Assist in conducting interviews for relevant job roles pertaining to clinical data management.
Education
Welingkar Institute of Management
Post Graduate Diploma in Healthcare Management, Healthcare and Pharmaceuticals
2015 — 2017
Dr. Bhanuben Nanavati College of Pharmacy
Bachelor of Pharmacy (B.Pharm.), Pharmacy
2010 — 2014
N.H. English Academy
Secondary School Certificate (SSC)
1996 — 2008
Thakur College of Science & Commerce
Higher Secondary School (HSC), Science
2008 — 2010
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.