RAVE
SACHIN DATANIYA
Clinical Data Management Professional
Ahmedabad
Summary
Well versed in designing of eCRF, discrepancy management, edit check testing, medical coding and preparing required documents related to CDM within timelines.
Experienced with data analysis and management, ensuring integrity and accuracy of clinical data. Utilizes statistical software and data visualization tools to support clinical research. Track record of collaborating with cross-functional teams to deliver actionable insights.
Overview
9
9
years of professional experience
Work History
Senior Clinical Data Analyst (Assistant Team Lead)
Ethicare Clinical Trial Services
04.2023 - Current
- Review CRF/eCRF data for completeness, accuracy, and consistency via computerized edits and manual data checks
- Perform external data reconciliation (Lab Data, IWRS, ECG, Medical Imagine etc.)
- Perform Serious Adverse Event reconciliation
- Generate and close/resolve (as appropriate) data queries
- Freeze and/or lock eCRFs (as appropriate) within the Electronic Data capture system
- Perform User Acceptance Testing and collaboratively work with CDMS personnel to see issues found through re-testing and resolution
- Identify and resolve data discrepancies in clinical data via computerized and manual data checks
- (DM listing, Structural listing, CPT listing etc.)
- Be compliant with Standard Operating Procedure, work procedures and project scope of the work and ensure quality
- Co-ordinate with other study team members for data management related tasks on study activity
- Work with other members of the project team
- This includes but is not limited to External team, Programmer, Statistician, Monitor and CRA
- Mentoring and Coaching New Joiner(s) and Team Members on CDM Process and SOPs as per assignment if assigned
Senior Officer
Cliantha Research Ltd
03.2021 - 06.2022
- Create, maintain and update study specific documents like Data Management Plan, Creation of Data Validation Plan, database design specifications, external data handling plan and other study specific documents
- Co-ordinate with other study team members for data management related tasks on study activity
- Perform UAT in study database based on the edit checks created
- Check consistency of Data Entry screens with case report form
- Train the clinical sites on using the study specific database for Electronic Data Capture (EDC) studies
- Identify and resolve data discrepancies in clinical data via computerized and manual data checks
- Perform data management QC for assigned study
- Handle the external data and perform the applicable external data reconciliation process and resolve queries pertaining to the external data
- Perform Serious Adverse Event (SAE) Reconciliation and resolve queries pertaining to the SAEs
- Perform Medical Coding of terms reported on Case Report Form
- Be compliant with Standard Operating Procedure, work procedures and project scope of the work and ensure quality
- Maintain documentation of training as appropriate
- Work with other members of the project team
- This includes but is not limited to External team, Programmer, Statistician, Monitor and CRA
- Conforms to training schedule for self, maintains awareness of SOP content in the Data Management team, according to company requirements
Technical Associate
Lambda Therapeutic Research Ltd
05.2018 - 03.2021
- Follow Data Management Plan requirement throughout the project
- Preparation and review of documents generated during life of project
- E.g
- Case Report Form (CRF), CRF Completion guideline, Data Validation Plan (DVP), Edit check document, Project specific self-evident correction etc
- Database designing and testing
- Edit checks implementation, testing and documentation
- Data validation includes DCF generation and resolution, manual review of clinical data to check the discrepancy (ies)
- Correction of clinical data as per investigator’s suggestion or Self-evident correction
- Preparation and review of other document related to CDM process and projects
- Check study specific CDM binder for completeness and correctness of required documents
- Maintenance of study binder in eTMF
- Coordination within and across the department for project related activity
- Medication coding by WHODD
- Follow the CDM SOPs, other departmental SOPs and applicable regulatory guidelines
- ECRF preparation and finalization for EDC module
- Conforms to training schedule for self, maintains awareness of SOP content in the Data Management team, according to company requirements
Clinical Research Coordinator
Bodyline Hospitals
06.2016 - 04.2018
- Screened patient records, databases and physician referrals to identify prospective candidates for research studies
- Collected data and followed research protocols, operations manuals and case report form requirements
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols
- Maintained compliance with protocols covering patient care and clinical trial operations
- Collected, evaluated and modeled collected data
- Gathered, processed and shipped lab specimens
- Followed informed consent processes and maintained records
Education
SAS Certified Specialist - Base Programming Using SAS 9.4
SAS Global Certification Program
05.2024 -
Base And Advance SAS Certified Course - Statistical Programming
Great Online Training
06.2022 - 04.2023
B. Pharmacy -
Gujarat University
06.2006 - 04.2011
HSC -
State Board of Gujarat
04.2004 - 04.2006
SSC -
State Board of Gujarat
04.2003 - 04.2004
Skills
- Discrepancy management
Data cleaning
Data validation
Data reconciliation
Medical coding
SAS programming
Database design
Time management
Problem-solving abilities
SOP development
Data monitoring
Clinical Research Therapeutic Area
- Rheumatology: Rheumatoid arthritis
- Oncology: Triple-negative breast cancer, Multi-organ Cancer
- Psychiatry: Schizophrenia
- Dermatology: Plaque Psoriasis, Skin infection
- Endocrine/Metabolic: Diabetic Neuropathy
- Cardiology: Post Myocardial Infarction Heart Failure
Software
Veeva
Code Angelo
Octalsoft
Biznet
Timeline
SAS Certified Specialist - Base Programming Using SAS 9.4
SAS Global Certification Program
05.2024 -
Senior Clinical Data Analyst (Assistant Team Lead)
Ethicare Clinical Trial Services
04.2023 - Current
Base And Advance SAS Certified Course - Statistical Programming
Great Online Training
06.2022 - 04.2023
Senior Officer
Cliantha Research Ltd
03.2021 - 06.2022
Technical Associate
Lambda Therapeutic Research Ltd
05.2018 - 03.2021
Clinical Research Coordinator
Bodyline Hospitals
06.2016 - 04.2018
B. Pharmacy -
Gujarat University
06.2006 - 04.2011
HSC -
State Board of Gujarat
04.2004 - 04.2006
SSC -
State Board of Gujarat
04.2003 - 04.2004
Similar Profiles
Matthew ReaderMatthew Reader
Sr. Laboratory Data Manager at CTI Clinical Trial and Consulting ServicesSr. Laboratory Data Manager at CTI Clinical Trial and Consulting Services
JILL L. DORANJILL L. DORAN
Manager, Account Management at CVS Health - Clinical Trial ServicesManager, Account Management at CVS Health - Clinical Trial Services
Arielle RomanoArielle Romano
Nurse Coordinator at Clinical Trial MediaNurse Coordinator at Clinical Trial Media