Karishma Shaikh
Mumbai,India
Summary
Skilled professional with expertise in clinical trials and proficiency in SAS software. Strong background in data management, including eCRF forms and medical terminology. Experienced with Clinical Data Management Systems such as InForm and Rave, alongside advanced MS Office skills. Recognized for effective communication, detail orientation, and ability to prioritize tasks for successful project outcomes.
Overview
5
5
years of professional experience
3
3
years of post-secondary education
1
1
Certification
Work history
Intern statistical programmer
Smart clinical
Bangalore, India
10.2024 - 03.2025
- · Good understanding of CRF Annotations, Mapping Specification Writing, Pinnacle 21 Report and creating SDRG and ADRG .
- Good working experience on SAS-BASE, ADVANCED-SAS/SQL/MACROS/R Programming.
- Experience on creation and validating of SDTM, ADAM Datasets, Listings
- Extensive knowledge on clinical programming, clinical trials (all three phases) in therapeutic areas like Neuroscience, Diabetic etc.
- · Proficiency in developing routine and Data manipulation in project-specific SAS Macros .
Sr. Medical coder
Aquity solutions, India Private Limited
Navi Mumbai, India
03.2020 - 10.2022
Education
MSc - Healthcare management and Leadership
Worcester University
United Kingdom 09.2022 - 10.2023
Master of Pharmacy - Pharmacology
University of Pune
Pune 09.2012 - 10.2014
Skills
- Knowledge of clinical trials Phases
- Proficient in SAS software
- Understanding of ICH-GCP guidelines local regulatory requirements
- Expertise in data management tasks
- Familiarity with eCRF forms
- Strong medical terminology and In-depth physiology Comprehensive pharmacology knowledge
- MS Excel, MS Office and Outlook proficiency
- Basic knowledge of medical terminology and coding dictionaries (eg MedDRA & WHODRUG)
- Basic knowledge of Clinical Data Management Systems (eg InForm, Rave, Veeva, Datalabs, ClinBase)
- knowledge of Data Management Operational processes and tasks during study start-up, conduct and close-out
- Effective communication abilities
- Strong interpersonal capabilities
- Ability to prioritize tasks
- Collaborative team player
- Detail-oriented approach
- Logical reasoning and problem-solving
Certification
SAS for Statistical Programmer(03/2025)
Learnt Base, Advance SAS, R Programming's, ADAM, TLF
Languages
English
Fluent
Hindi
Native
Marathi
Native
Timeline
Intern statistical programmer
Smart clinical
10.2024 - 03.2025
MSc - Healthcare management and Leadership
Worcester University
09.2022 - 10.2023
Sr. Medical coder
Aquity solutions, India Private Limited
03.2020 - 10.2022
Master of Pharmacy - Pharmacology
University of Pune
09.2012 - 10.2014
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