SUBHASH CHANDRA PATEL
To gain experience and provide best service and productivity by hard work and teamwork in a clinical research industry rendering competitive environment and challenging responsibilities so that I can surpass in that field and work for the betterment of my organization.
Total experience - Over 7 year and 7 months experience in Clinical research industry.
Databases- Inform, RAVE, RAVEX, Oracle clinical,
Visualization tool- Spotfire.
CDM Tool- SPECTRE, EDU.
Perception of Centralized Monitoring Model L1/L2 process, IPD process, Query Escalation pathway, Clinical application of medical terminology and Centralized Monitoring model tools.
Knowledge of Advance Excel.
Ability to handle multiple Projects.
Leadership, Teamwork, Willingness to Learn, Self-Motivated.
1. Date of Employment: 20/05/2019 - Present
Job Title: Clinical Data Manager
Organisation Name- Novartis, Hyderabad
Department- Clinical Data Management
Provide professional DM input on Clinical Trial Team(s)
Input to and review of clinical trial database design including User Acceptance Testing (UAT).
Responsible for the Validation and Analysis Plan (VAP) meeting for the clinical trial, which includes chairing the meeting, writing the study specific validation checks and necessary reports to ensure high quality and consistent data.
Identify errors and inconsistencies; resolve them or initiate their resolution either via the field monitor or directly with the investigational site, to ensure high quality and timely database locks.
Review and contribute to preparation of protocols, specifically related to the data management section, visit schema and study design.
Prepare Case Report Forms (CRFs) and CRF completion Guidelines (CCGs), electronic or paper.
Support and provide leadership for data management staff for allocated trials.
Freeze and lock data as appropriate in time for statistical review, blinded interim quality review, interim and final database lock.
Perform training on data management software and practices or trial specific topics as required.
Prepare training materials for data management activities and processes as required.
Travel is required as needed
Date of Employment: 23/08/2016 – 10/05/2019
Job Title: Business Process Lead- (Data Processing)
Organisation Name- Tata consultancy Services, Mumbai
Department- Clinical Data Management
Test script writing and eCRF screen review.
Review and understand the study protocol and timelines.
Monitor reports on the queries raised and provide the metrics for the same.
Action study team feedback as required on the data.
Escalate any discrepancy in the clinical data to the Study team as appropriate.
Review the resolved discrepancies and close where appropriate.
Providing query metrics as per the request of the query manager.
To ensure an error free, quality data with no open queries.
Understand and review dataset specifications.
Execute external checks, to handle manual discrepancies and action the same.
Awareness of external vendor data requirements.
Escalate performance and quality issues to Study team for resolution with the vendor.
Ensure reconciliation of all the study data as per the study manger’s request.
Execution of SAS checks.
Working on external data reconciliation i.e.PK, PGx LAB.
Freezing and locking of casebooks.
Validation of external vendor data.
Address the post DBR and DBF queries.
Liaise with the sites and monitoring to ensure all eCRF’s signed.
2. Date of Employment: 12/06/2014 – 11/08/2016)
Job Title: Medical Data Reviewer- (Centralized Monitoring)
Organisation Name- Quintiles Technology, Bangalore
Department- Clinical Data Management
•Identify any anomalies in patient reported data that require further investigation with the clinical site to determine overall accuracy
•Review all inclusion and exclusion criteria to ensure each patient meets minimum level of acceptance into the clinical trial
•Review investigation product dosing records to determine adherence to protocol and identify possible inaccurate / missed dosages
•Review all reported Adverse Events (AEs), Concomitant Medication and medical history information to ensure all supporting information is expected and/or implausible data is verified and adherence to protocol expectations and its impact on other patient reported/observed information (e.g., laboratory results, AEs, etc.)
•Ensure end-of-treatment (EOT) and end-of-study (EOS) information is correctly documented to determine primary reason for the patient ending treatment or ending participation in the clinical trial
•Review all laboratory results to ensure completeness of information and adherence to protocol schedule of events and determine if reported laboratory values represent a potential safety condition not reported in the AE information for the patient
•Review any other information as necessary to determine overall readiness of the patient information for next level review
•Interaction with other Medical review staff to verify information and/or triage new data issues or prior identified action items
•Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
3. Duration of Employment: 07/03/2012–11/06/2014
Job Title: Clinical Trial Analyst
Organisation Name- Indegene Lifesystems Pvt. Ltd., Bangalore
TrialPediais a repository and analytical platform for global clinical trials that aids in understanding the clinical trial landscape and its competitive environment.
Role and Responsibilities:
Scientific and Competitive Intelligence: Expertise in secondary research, use of databases to mine information, preparing deliverables such as company reports, therapy area reports, Trial Maps, and pipeline analysis reports.
Analyzing clinical trials Competitive landscape from secondary sources like Clinicaltrials.gov, WHO, ANZCTR, UMIN and various other countries clinical Trial registries.
Data mining and data harvesting for sites, investigators and sponsors.
Data analysis by using different MS Excel formula (Fuzzy Vlookup, Pivot table).
Advise data management staff on trial parameters, database designs, and validation of critical data.
Statistical analysis and competitive analysis of trial results.
Clinical trial data analysis, tagging and updating the database.
Qualitative and quantitative analysis of various trial results published in abstracts of various conferences across general medicine and oncology indications.
Analyzing and generating clinical trials reports from Published articles and from other authenticated source.
Lotus Clinical Research Academy, Bangalore
July 2011 – February 2012 (8 months) Bangalore
Training on different Regulatory Guidelines pertaining to Pharmaceutical Industry and Clinical Research such as FDA, EMA and ICH (CTD).
Hands on Training on Oracle Clinical, SAS and Oracle AERS.
SOP, Protocol Writing.
CRF Design, Database build.
M. Pharm. in Clinical Research from Birla Institute of Technology, Mesra, Ranchi in 2012 with 7.78 GPA.
B.Pharm from Swami Vivekanand College of Pharmacy Indore in 2010 with 66.15%.
Received Star Performance award for achieving DBR before timelines for 3 studies (2017&2018).
Work worth doing (Bravo) for Customer Service in Mar 2015.
Two Research Paper Publications in International Journal.
Name : Subhash Chandra Patel
Father’s Name : H. L. Patel
Sex : Male
Marital Status : Married
Nationality : Indian
Hobbies : Listening to music, Travelling, Playing Badminton and Cricket.
Phone No : +91-099********
Date of Birth : 16-12-1985
I hereby declare that the above-mentioned information is correct up to my knowledge and I bear the responsibility for the correctness of the above-mentioned particulars.
Place: Mumbai (Subhash Chandra Patel)