RAJU THOMBRE
Clinical Data Manager
Summary
Over 10.5 years of experience in different domains of life sciences, helped me to grow in the field of clinical research. As a clinical data manager, my career mostly revolves around Clinical Data. The diverse experience I bring on the table, really help me to thoroughly understand the clinical trials. With this versatile experience, I can view the CTs not only with CDM's point of view but also with the Clinical Science (CS), Protocol Designer and Statistician's point of view.
Overview
11
11
years of professional experience
2013
2013
years of post-secondary education
3
3
Certifications
Work History
Clinical Data Programming Scientist
Accenture Solutions Private Ltd
04.2024 - Current
Roles: Clinical Data Manager
Responsibilities: Study Set Up-Conduct-Close Out
STUDY SET UP:
- UAT for 'Adverse Event Reconciliation Tool'
- Designing study structure ( Metrics Design Document-MDD)
- eCRF Designing (Architect Loader Spreadsheet-ALS)
- Designing Edit Checks (Study Logic and Check Specifications-SLACS)
- Implementing the protocol amendments to study database (Migrations)
- User Acceptance Testing (UAT) in Rave- All levels while study setup
- Data Management Plan (DMP)
- Data Quality Review Plan (DQRP)
- Preparation of eCRF Completion Guidelines (eCCG)
STUDY CONDUCT:
- SAE Reconciliation
- Imaging Data (MRI, CT, PET Scan Data) Reconciliation
- Spotfire Report Review, Data Handling Specifications (DHS)
- Lab Reports Review (Range Accuracy, Blood Differential Cells Data)
- Manual Listings as per requirements
STUDY CLOSE OUT:
- Early Site Closures (ESC)
- Freezing of Data
Clinical Data Manager (Business Process Lead, BPO3)
Tata Consultancy Services
06.2021 - 04.2024
Roles: Clinical Data Manager, Study Data Team Lead (For 2 Oncology Studies)
Responsibilities: Study Set Up-Conduct-Close Out
STUDY SET UP:
- Designing study structure ( Metrics Design Document-MDD)
- eCRF Designing (Architect Loader Spreadsheet-ALS)
- Designing Edit Checks (Study Logic and Check Specifications-SLACS)
- Implementing the protocol amendments to study database (Migrations)
- User Acceptance Testing (UAT) in Rave- All levels while study setup
- Data Management Plan (DMP)
- Data Quality Review Plan (DQRP)
- Preparation of eCRF Completion Guidelines (eCCG)
STUDY CONDUCT:
- SAE Reconciliation
- Imaging Data (MRI, CT, PET Scan Data) Reconciliation
- Spotfire Report Review, Data Handling Specifications (DHS)
- Lab Reports Review (Range Accuracy, Blood Differential Cells Data)
- Manual Listings as per requirements
STUDY CLOSE OUT:
- Early Site Closures (ESC)
- Freezing of Data
- Database Lock (DBL)
Sr. Executive (Test Data Reviewer)
Cipla Ltd.
12.2018 - 06.2021
Roles: Team Lead (Microbial Testing Team-Microbiology)
Responsibilities: Testing Data Review, Get all product testing done on timely manner from team, Assays, Report Writing, CAPA
Clinical Science (Research Associate R-2)
Wockhardt Research Centre
04.2016 - 12.2018
Clinical Science (Industrial Trainee)
Wockhardt Research Centre
08.2015 - 04.2016
Roles: Clinical Data Manager, Clinical Science
Responsibility:
- Clinical Data Management
- Patient Data Review
- Discrepancy Management
- Protocol Designing (Dosing Part)
- Microbial Data Analysis
- Lab Reports Review, Manual Listings (As per requirements: Duplicate AE, Duplicate CM etc.)
Jr. Officer
Atra Pharmaceuticals Ltd.
02.2014 - 05.2015
Roles: Team Lead (Microbial Testing Team-Microbiology)
Responsibilities: Testing Data Review, Perform all product testing on timely manner, Assays, Report Writing
Education
M.Sc. - Biotechnology
Lovely Professional University
Phugwara, PunjabB. Sc. - Biotechnology
Azad College
HSC - undefined
Deogiri College
SSC - undefined
Sushila Devi Viddhyalay
Skills
- Clinical Data Management (Set Up, Conduct, Close Out)
- Clinical SAS, Python, SQL, Advance Excel, Power BI
- ICH-GCP, CDISC-SCDM
- RAVE-EDC, LIMS, TIBCO Spotfire, Dolphin, StarFish
- Leadership: Team Building, Work Allocation, Project Planning, Communication
- Report Writing
Certification
1. Advanced Certification in Data Science and AI, 03/01/22 to 02/01/23, IIT Madras
Languages and Soft Skills
- English - Proficient/ Hindi - Proficient/ Marathi - Fluent
- Highly professional & proactive approach with strong work ethics towards the assigned job.
- Good written and verbal communication skills.
- Ability to manage competing priorities effectively.
- Excellent organizational and problem-solving skills.
Qualified Examination
GATE 2014, Biotechnology ( All India Rank -1640, Score - 353)
Timeline
Clinical Data Programming Scientist
Accenture Solutions Private Ltd
04.2024 - Current
Clinical Data Manager (Business Process Lead, BPO3)
Tata Consultancy Services
06.2021 - 04.2024
Sr. Executive (Test Data Reviewer)
Cipla Ltd.
12.2018 - 06.2021
Clinical Science (Research Associate R-2)
Wockhardt Research Centre
04.2016 - 12.2018
Clinical Science (Industrial Trainee)
Wockhardt Research Centre
08.2015 - 04.2016
Jr. Officer
Atra Pharmaceuticals Ltd.
02.2014 - 05.2015
B. Sc. - Biotechnology
Azad College
HSC - undefined
Deogiri College
SSC - undefined
Sushila Devi Viddhyalay
M.Sc. - Biotechnology
Lovely Professional University
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