Headline

Clinical Data Manager | 5 Yrs Exp | Oncology | End-to-End CDM | CDISC, SDTM, Setup, Medidata Rave, UAT, Database Lock | J&J, AbbVie | Open to CDS, CDA, CDR, CRC, CRA, CDC & Trial Data Role | Abu Dhabi, Dubai UAE | Remote

About

I am a Clinical Data Manager with 5 years of experience supporting Phase I–III global clinical trials, with specialized expertise in Oncology studies. I have contributed to high-impact projects for leading sponsors, including Johnson & Johnson and AbbVie, supporting end-to-end clinical data management activities with a strong focus on data quality, compliance, and clean data delivery. My experience covers end-to-end CDM activities across study setup, conduct, and closeout phases, including EDC setup, test script creation, UAT, DRM data entry, SAE reconciliation, cross-functional communication (collaboration with global study teams), CRF review, data cleaning, query management, external data reconciliation, protocol deviation review, and database lock readiness. I am experienced with EDC and clinical data systems including Medidata Rave-X, Classic Rave, InForm, Jarvis, Data4You, and Spotfire. I also have working knowledge of CDISC-compliant data standards including CDASH and SDTM, along with ICH E6 GCP-regulated clinical trial environments. One of my key strengths is identifying root causes behind data quality issues and implementing practical corrective actions. I am currently based in Abu Dhabi, UAE and available immediately for Clinical Data Manager, Clinical Data Specialist, Clinical Trial Data, EDC, Clinical Research, and Clinical Operations-related roles across the UAE. Core areas of expertise: Clinical Data Management | Oncology Clinical Trials | Medidata Rave-X | Classic Rave | SAE Reconciliation | CDISC | CDASH | SDTM | ICH-GCP | EDC Setup | UAT | Data Cleaning | Query Management | Vendor Reconciliation | Protocol Deviation Review | Database Lock | Data Quality | Clinical Trial Operations

Location

Abu Dhabi Emirate

Work experience

Clinical Data Specialist at IQVIA, Mar 2024 - Apr 2026 · 2 yrs 2 mos, India, Support Clinical Data Management activities for global oncology clinical trials across study setup, conduct, data review, and database lock readiness phases. Spearheaded setup-phase activities for two Johnson & Johnson-sponsored oncology studies, including test script creation, UAT, DRM data entry, SAE Reconciliation and form UAT, contributing to successful on-schedule study go-live. Led data review and conduct-phase activities, including external data reconciliation, Query Discrepancy Resolution, protocol deviation review, and CDISC-aligned data quality checks. Developed and delivered a site training presentation to guide correct form completion and expected data updates, helping eliminate manual query backlog and prevent further protocol deviations. Coordinated with global cross-functional teams, vendors, programmers, study teams, and quality leads to ensure timely issue resolution, clean-data readiness, and high-quality deliverables. Delivered weekly study status updates, tracked key data issues, and maintained consistent data quality with no sponsor escalations. Received appreciation from the Global Data Manager and Study Lead for being reliable, proactive in taking up new and complex tasks, and consistently delivering high-quality, clear, and well-structured outputs.

Clinical Data Specialist at Cognizant, May 2021 - Mar 2024 · 2 yrs 11 mos, Mumbai, 1) Profound familiarity with a wide range of databases including Classic Rave, I Medidata, Jarvis, Edit Check Engine, and more. 2) Experienced in third-party vendor data reconciliation encompassing pharmacodynamic, pharmacokinetic, and pharmacogenetic data, along with SAE reconciliation. 3) Proficiently engage with vendors to resolve missing data issues and discrepancies, ensuring comprehensive data accuracy. 4) Collaborate closely with programmers to optimize edit checks, maintaining data accuracy. 5) Exemplary commitment to adhering to SLAs and GCP standards, ensuring data quality and compliance. 6) Conduct rigorous data cleaning across diverse listings, ensuring accuracy in lab, non-lab, and other critical assessments. 7) Mentor team members in data management tools, fostering growth and knowledge sharing. 8) Manage multiple timeline studies effectively, ensuring seamless progress thorough bulk data cleaning, encompassing raw data review and resolution. 9) Liaise with Quality and Program leads to swiftly address discrepancies. 10) Generate Clean Patient Trackers and HOS reports as requested by study teams & execute vital activities during final database lock, including padlocking, IDRP completion, and meticulous eyeball reviews.

Trainee Junior Data Analyst at Cognizant, May 2021 - May 2022 · 1 yr 1 mo, contributed to 3 additional trials for global sponsors like Abbvie, managing database lock activities, vendor reconciliation, and core CDM deliverables in alignment with regulatory requirements. Improved data integrity and operational workflows by executing automated and manual reconciliation checks, proactively resolving discrepancies, and ensuring timely delivery of clean, consistent data. Delivered Clean Patient Tracker and HOS Reports during project timelines while supporting overall final database lock processes through effective coordination and quality control. Mentored junior team members, facilitated onboarding, and improved CDM processes through training, trend analysis, and proactive issue resolution.

Intership at BIONEXT PHARMA PRIVATE LIMITED, May 2018 - Jun 2018 · 2 mos, Mumbai, Gained exposure to pharmaceutical manufacturing, formulation processes, SOPs, quality control, and quality assurance activities. Observed manufacturing processes for syrups, tablets, and capsules while understanding cGMP, cGLP, documentation, and quality requirements. Developed foundational knowledge of the pharmaceutical product lifecycle, from development to manufacturing and quality review.

Education

Master of Pharmacy, Pharmaceutics and Drug Design, Mumbai university

Master's degree, Pharmaceutics, Shri D.D Vispute College Of Pharmacy & Research Center