KRITHIKA PREMKUMAR
Memphis,TN
Summary
Meticulous Clinical Informatics Analyst, passionate about clinical trials and genomics. Well-versed in Clinical database and statistical programming with expertise in building and validating clinical studies and all aspects of SAS programming applied in Phase I - IV with the ability to lead and execute projects, producing quality outcomes through leadership and team motivation in a pharmaceutical scientific informatics-based organization. Excited to partner with a goal-oriented organization and to take on added responsibilities to achieve the organization's goals.
Overview
4
4
years of professional experience
Work History
Senior Clinical System Analyst
Zifo RnD Solutions
10.2020 - 06.2021
- Managed over 25 complex clinical studies with tight deadlines and successfully delivered quality deliverables including electronic Case Report Forms and edit checks in different EDCs following CDASH standards
- Proactively managed task and people allocation, scope changes in project, and risk mitigation and ensured that project budget is met
- Performed issue resolution within team as well as with customers
- Served as point of contact for numerous customers across globe
- Supervised and ensured team's compliance with organization's policies
- Performed the role of Gating reviewer in various studies in different EDCs, ensuring quality alignment of design and development with customer requirements
- Approved various project plans and quality standards of deliverables
- Performed migration of clinical data from one EDC to another LIVE EDC environment by creating mapping specifications, converted datasets and double QC of converted files
- Coordinated training for freshers by creating training plans ensuring plan alignment
- Provided technical mentoring to freshers on various EDCs enabling them in design and development along with an overview of internal processes
- Initiated and coordinated conduction of process refreshers for team and tracked process-related action items to closure
- Actively participated in different process-related initiatives and authored work instructions for test script writing
- Identified issues, analyzed information and provided solutions to problems.
Clinical System Analyst
Zifo RnD Solutions
03.2019 - 10.2020
- Extensively played the role of Developer/ Tester / Reviewer and delivered quality deliverables including eCRFs and edit checks in different EDCs like Medrio, Staicy Nodes, Rave and ClinCapture aligning with the project plan for around 50 studies
- Generated highly complex custom Reports and standard Reports in Xclinical's Marvin using PostgreSQL for 50+ studies
- Created efficient test scripts for edit check reviews
- Designed an enhanced Report specification template
- Reviewed revised versions of Report generation SOP
- Drafted validation documentations for ePRO features in Medrio
- Assisted validation department in creating sample SAS datasets to test their automation tool
Associate and Programmer Analyst
Zifo RnD Solutions
09.2017 - 02.2019
- Performed all technical activities facilitating creation of FDA submissions with gained cognizance in CDISC standards and all applicable regulations of Phase I to IV
- Programmed and generated development as well as QC datasets for nearly 15 projects following SDTM, ADaM and TFLs guidelines and good coding practices
- Independently played the role of Designer/Developer/Tester /Reviewer to create quality and timely delivery of all FDA deliverables including Data extract datasets, Analysis datasets, Tables, Listings, Graphs, Define.xml and annotated CRFs following the company's SOPs
- Actively participated in all technical initiatives, creation of SAS macros and shared ideas to automate development of FDA deliverables
- Worked on initiatives including creation of library for data extract specification and primary programs
- Have gained knowledge of how to handle clinical data, lifecycle of a clinical trial, roles and responsibilities involved, and information/ standards related to patient consent and safety
- Assisting the Business Development team by gathering inter-departmental knowledge and sharing best-in-class content in Clinical Events taking place across the globe
Education
Master of Science - Genomics (Informatics)
University of Southampton
Southampton, United Kingdom12.2022
Bachelor of Engineering - Biomedical Engineering
PSG COLLEGE OF TECHNOLOGY
Coimbatore, India04.2017
Skills
- DOMAIN SKILLS
Genomics-related skills:
- Variant annotation
- Filtering of potential variants and quality assessment
- Bioinformatic pipeline creation in Galaxyorg
- Using Machine learning in genomics Interpretation of genomic variants based on ACMG guidelines
- Performing cell cultures for fibroblasts, RNA extraction, cDNA synthesis and real-time quantitative Polymerase chain reaction (RT-qPCR)
- Gene expression analysis
- Single-cell RNA sequencing analysis – using the Seurat package
- Using Python and R for genomic data
Statistical programming skills:
- Therapeutic area expertise includes Oncology, Vaccines, Liver disorders, Teeth implants, Eating and sleep disorders
- SAS programming to create SDTM, ADaM datasets and creation of Tables, listings, and graphs
- Proc SQL
- Creating definexml
- Annotating aCRF Creating clinical reports using PostgreSQL
- Standards and other clinical domain knowledge: CDISC standards including CDASH, SDTM, ADaM, Tables and Listings
- GDPR and ICH guidelines for Pharmaceutical Industry
Database programming skills:
- PostgreSQL
- Clinical data migration Design, develop and quality check clinical studies in EDC platforms including Staicy nodes, Medrio, ClinCapture, Rave, Marvin
- Design, develop and quality check clinical reports in EDC platforms: Marvin and Rave
Other Programming/ Software/ Databases:
- MySQL, JAVA, Arduino, Bash scripts
- Signal processing and Image processing in MATLAB 71
Timeline
Senior Clinical System Analyst
Zifo RnD Solutions
10.2020 - 06.2021
Clinical System Analyst
Zifo RnD Solutions
03.2019 - 10.2020
Associate and Programmer Analyst
Zifo RnD Solutions
09.2017 - 02.2019
Master of Science - Genomics (Informatics)
University of Southampton
Bachelor of Engineering - Biomedical Engineering
PSG COLLEGE OF TECHNOLOGY
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