Noorunissa Rehman Shaikh
Mumbai
Summary
With an overall experience of 10 years, I aspire to work in a dynamic, challenging environment and significantly contribute to the organization’s objectives, which will also support my growth alongside the organization. I aim to undertake challenging assignments to continuously learn and enhance my skills.
Professional in data management, prepared to drive results through impactful leadership. Extensive experience in project oversight and process enhancement. Reliable team collaborator, adaptable to changing needs, with strong analytical and problem-solving skills.
Overview
10
10
years of professional experience
Work History
Associate Data Team Lead
IQVIA
Bangalore
10.2025 - Current
- Designing and providing technical support to different phases of trial and different TA during set up of the study.
- Worked on Set up of the study
- Created Architect Loader Sheet
- Created SDRS
- Created DRT/DER (Data Requirements)
- Created Data Management Plan
- Conducted EDC Demo session
- Worked in liaison with the System designer and programmer
- Edit Check writing
- Performed User Acceptance Testing of Database
- Document creation and maintenance in eTMF
- Working on set up for different TA.
Data Analyst
Cognizant
Airoli, Mumbai
09.2022 - 09.2025
- Handled assigned study end to end with a team of 2 members at least in all phases of the study and different phases of trial.
- Lead a study independently collaborating with cross functional teams
- Performed Manual review of Data
- Performed Listing review of Data
- Performed SAS data review
- Conducted ECG reconciliation
- Conducted Lab data reconciliation.
- Worked on Migration to perform any changes Post productions and implementations.
- Responsible for Quality control
- Performed User Acceptance Testing for database/edit checks
- Trained and mentored team members
- Worked on end-to-end phase of study. (Set Up, Conduct and close out)
- Performed Query management
- Performed Reports review
- Maintained and created study setup, conduct, and closeout documents
- Independent Client interactions.
- Performed SAE reconciliation
- Edit Check Writing
Senior Process Associate
TCS
Thane, Mumbai
06.2021 - 09.2022
- Worked on a pilot project on one of the largest clients and 2 of the high priority studies as a liaison between Data management and LAB data management.
- Performed Lab Data reconciliation
- Performed Lab Sample reconciliation
- Training of team member
- Performed Knowledge Sharing session
- Addressed client concerns and issues via Client interaction
- Interact with Lab to assist with data management issues
- Lab and Data management query management
Clinical Data Specialist
IQVIA (Contract Basis)
Thane, Mumbai
06.2018 - 04.2019
- Led a team of 5 in a project converting paper data to electronic format.
- Part of one of IQVIA pilot project converting paper trials into electronic format
- Addressed sponsor queries
- Conducted manual checks
- Reports review
- Worked on a database BOX
- Single data entry and double data entry
- Quality check and control
- Client interactions
- Training of associates.
- Supported DM activity like Manual review
- Created team Matrices and leave trackers
Junior Data Analyst
Cognizant
Mumbai
04.2011 - 03.2015
- Mentored peers on various documents and processes
- Worked on Study setup, conduct, and closeout activities more than 2 studies.
- Query Management
- Reports review
- Worked as a second in command to the lead of the study
- Performed coding
- Performed Validation
- Database cleaning for final DBL (Database Lock)
- Edit check writing
- Report writing
- Clintrial database report review
- SAS report review
- Manual Data review
Education
Advance Post Graduate Diploma - Clinical Research
Clinical Research Education And Management Academy (CREMA)
Mumbai01-2010
B.Sc. - Biotechnology
Mumbai University
Mumbai04.2008
Skills
- Clinical Data Platforms:
- iMedidata Rave
- VEEVA EDC
- Inform
- Clintrial
- BOX
- SAS portal
- Jarvis
- Tools:
- BO
- SAS
- SQL
- Advanced Excel
- Soft Skills:
- Team management
- Training & development
- Conference call etiquette
- Email Etiquette
- Client Interaction
Languages Known
English
Hindi
Marathi
Aspire to take up an international language soon.
Disclaimer
Place: Mumbai Date: May, 2026 Noorunissa Abdul Rehman Shaikh Signature: ________________________
Over all Project Experience
- Strong knowledge of Clinical Trials and Good Clinical Practice (GCP)
- Expertise in study start-up, conduct, closeout, and discrepancy management
- Proficient in INFORM 4.6, Clintrial 4.5, Medidata Rave, and BOX.
- Proficient with Veeva EDC and eTMF.
- Worked on JARVIS.
- Worked on missing data engines.
- Vendor reconciliation
- UAT
- SAE Reconciliation.
- Experience with clinical protocols in multiple therapeutic areas, including vaccines
- Performed data management, UAT, query resolution, and documentation preparation
- Conducted manual data checks and created study-specific reports
- Managed lab data reconciliation and collaborated in cross-functional team meetings
- Training and mentoring
- Independently handling the study
- Leading a team of minimum 5 team members
- People management Skills
Trainings
- Prompt Engineering
- ICH GCP
- Email Etiquettes
- Use of AI
Timeline
Associate Data Team Lead
IQVIA
10.2025 - Current
Data Analyst
Cognizant
09.2022 - 09.2025
Senior Process Associate
TCS
06.2021 - 09.2022
Clinical Data Specialist
IQVIA (Contract Basis)
06.2018 - 04.2019
Junior Data Analyst
Cognizant
04.2011 - 03.2015
Advance Post Graduate Diploma - Clinical Research
Clinical Research Education And Management Academy (CREMA)
B.Sc. - Biotechnology
Mumbai University