Development, testing and implementation of multiple projects for Pharmaceutical, CRO and Biotechnology companies.
• Working knowledge to review and understand study specific documents such as Protocol, SAP and CRF.
• Experience working with different phases (phase I to III) of clinical trial data of different therapeutic areas like CVS, Diabetic and Oncology.
• Worked as a Lead Quality Validator (LQV) for several studies and followed the organizational specific plan in production and QC of Datasets and TFLs for multiple deliverables.
• Extensive involvement in creating SDTM specification and SDTM domains by utilizing aCRF and SDTM IG incompliance with CDISC standards.
• Worked on various Safety and Efficacy Analysis datasets using ADaM IG.
• Experience in working on the Pinnacle 21 to check the consistency of the data in consistence with CDISC standards.
• Involved in creation and validation of Tables, Listings and Figures for several deliverables like CSR, IA etc.
• Ability to design, compose and debug macros and perform change controls on existing macros.
• Knowledge of regulations such as ICH GCP guidelines, FDA Code of Federal Regulations (CFR) – 21CFR11, MedDRA, WHO-DD and other Regulatory Submissions.
• Knowledge of Database Creation and Table Programming for Integrated Summaries of Safety (ISS).
• Experience in identifying data issues by writing Edit Checks to assist data management.
• Involved in production of CRT package - define.xml for FDA submission.
• Handled different protocols simultaneously and worked on various studies both as a production and validation programmer.
• Excellent analytical, critical thinking, verbal and written communication and interpersonal skills. Proactive, adaptable and well organized.
• Ability to work independently to accomplish goals.