D. LAXMAN KUMAR

• Performed high quality clinical data review to identify clinical data insights and trends through patient level review and trends analysis as directed by the Integrated Clinical Trial Team (iCTT).

•Contributed and facilitated for data review process improvements. e.g. identification of delinquent/redundant reports and/or implementation of innovative data analysis processes and tools (Qliksense, Spotfire and PowerBI).

• Contributed to providing meaningful insights right from the study start up till the close out activities (DBL) and provided inputs into study documents such as synopsis, protocol development, CRFs, CRF Completion Guidelines (CCG), Study Execution Plans (SEP), Clinical Data Review Plan (CDRp), Clinical Database edit specifications (ECS).

• Performed clinical data review as per Data Review/Quality Plan (DRP/DQP) and data review strategy, ensuring that protocol-level deviations (PD), eligibility criteria (IE), study assessments & other aspects of the protocol are implemented consistently across the study.

• Supported several Interim Analysis, Futility analysis, Database and Post lock activities and facilitated resolution of clinical data issues.

• Supported with data, protocol deviation review, study level trackers, and other issue logs in Veeva Vault and SPRINT.

• Collaborated with relevant line functions to enhance the quality of clinical data review/insights with an emphasis on the subject of safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review.

• Supported the pharmacovigilance activities (e.g., reviewing/contributing to patient narratives, attending Safety Monitoring Meetings (SMT)), prepared the SAE slide decks for the DMC (Data monitoring committee) meetings on regular basis.

• Supported in reviewing the Argus Safety narratives, CSR narratives and Clinical study reports shell review towards achieving the Database Lock.

• Supported several study deliverables (i.e. timelines, study plans, CTMS etc.) through collaboration with internal and external stakeholders to make robust data driven decisions.

• Supported in compiling the data for Investigator Brochure (IB) for different therapeutic areas.

• Supported in programming the study specific reports such as QTL’s (Quality Tolerance limits) and patient profiles (PP) for ongoing efficacy analysis by performing User Acceptance Testing (UAT) by contributing to the User requirement specification (URS) form.

• Supported the Data Management team on data reconciliation and Post production changes (PPC) for the Data Monitoring committee (DMC) and Database lock.

• Successfully achieved database lock for three critical trials and implemented the new data review approach during the COVID outbreak scenario.

• Received, triaged, and processed Lifecycle Safety data from various sources on time and within quality standards.
• Executed data entry in drug safety databases, including Oracle Argus Clinical.
• Ensured compliance with departmental SOPs for data capture and coding accuracy.
• Processed adverse event cases using Argus, maintaining high quality throughout.
• Selected appropriate event terms in MedDRA to ensure accurate coding.
• Authored narratives summarizing events per departmental SOPs for various case types.
• Maintained daily communication with clients and management to support timely task completion.
• Demonstrated proficiency in Microsoft Office Suite and MedDRA coding.

• Managed comprehensive document management processes, ensuring client expectations were met through targeted tools and regular communication.
• Collaborated with expert panels to gather and validate drug research data for tailored research projects.
• Developed extensive clinical trial databases, reviewing global regulatory submissions including NDA, ANDA, MAA, DMF, and ASMF.
• Contributed to research studies across various therapeutic areas such as cardiovascular disease, CNS, and oncology.