Senior Clinical Study Manager

• Apr 2022 - Present

Study Manager

• Sep 2020 - Present

Research Analyst

• Jan 2019 - Jul 2020

Client- Abbvie • Requirement specification gathering, documenting the requirements, hosting PoC demos, testing the delivered templates before the UAT using IDBS E-Workbook 10.4, IDBS E-Inventory 2.1, LIMS and Dotmatics. • Expert on Discovery/Pre-clinical/Clinical data, Requirements Management, Design, Development, Testing and Configuration Management. • Managing the study build team – held key responsibility of deliverables – with respect to Quality and timelines. • Strong knowledge of Laboratory Information Management System (LIMS) that is required to complete job responsibilities. • Good understanding and adherence with the SOPs, Guidelines and Work Instructions appropriate to the job function. • Perform the Scientific Application Analyst role on multiple projects for single/multiple customers simultaneously. • Highly efficient Individual contributor to the team and performs activities with minimal guidance. • Supports UAT and conducts WAR room sessions at times of Implementation/Go-Live. • Ensures completeness and thoroughness in all aspects of work - in terms of technical, domain, usability, documentation and process adherence. Show less

Research Analyst- Contractor

• Jan 2019 - Jul 2020

Clinical Research Associate

• Nov 2015 - Jan 2019

• Responsible for day-to-day activities necessary to facilitate the successful completion of each study in accordance with study protocol and clinical research regulatory requirements. • Involved in recruitment, consenting, determining eligibility, enrolling, and coordinating care while on study. • Assigned for maintenance of all regulatory study requirements, including modifications, continuing reviews, reportable events reporting, new study initiation, and study closures. • Strong working knowledge regarding guidelines from ICH-GCP, 21CFR Part11, and SOP's and coding dictionaries such as MedDRA, WHODrug. Show less

Clinical Data Coordinator

• Apr 2014 - Sep 2014

• Conducted activities of clinical research protocols including obtaining informed consent, reconsent, subject enrollment, subject eligibility criteria validation, maintaining patient charts • Maintaining data integrity by ensuring data entered in case report forms are accurate. • Responsible for Informed consent development, and its amendment. • Responsible for submitting regulatory documents to WIRB like initial study approval, study amendments, annual continuations and terminations. Show less

E-clinic Analyst

• May 2012 - Dec 2012

• GCP, 21 CFR Part 11, CDISC, SDTM, CDASH standards. • Act as quality control programmer to validate SAS programs that produce derived/analysis datasets and analyses specified in the Statistical Analysis Plan. • Optimized performance using Data Validation and Data cleaning on Clinical Trial data using Statistical procedures like PROC FREQ, PROC MEANS, and PROC UNIVARIATE. • Imported huge data in to SAS library and sorted according to the class of the drug using ORDER BY option. • Knowledge of regulation such as CDISC SDTM and ICH guidelines, also ADaM implementation of standardization for the analysis dataset. • Expertise in designing workflows using E-Workbook/ BioBook ELN product for Novartis, IDBS, Roche, Biogen Idec clients. • EDC (Electronic data Capture) - CRF/eCRF designing, study validation and edit checks for products. Show less