Summary
Overview
Work History
Education
Hobbies
Timeline
AccountManager
Prashant Nighut

Prashant Nighut

Clinical Data Manager
Navi Mumbai

Summary

I am Clinical Data Manager with 8.5 years of overall experience in end to end clinical data management. Hands on study set up, conduct and close out activities of clinical trials. Well versed in leading data management activities for multiple studies across diverse therapeutic areas. Experience in vendor management, quality review and training. Hands on experience on various analytical clinical tools and database User interfaces like Inform, RAVE, OC-RDC, Veeva- RDC, MS-Power BI, J-Review, MS-Office, SBIR, Client’s In-house RDC tools (eNable) and SAS Life-Science Analytics framework (LSAF) , SQL Developer.

Overview

9
9
years of professional experience
4
4
years of post-secondary education

Work History

Study Data Manager

Syneos Health
Mumbai
12.2019 - Current
  • Authors and adheres to the requirement of study specific DMP for assigned studies
  • Creates and enters test data for UAT, creation of Test plan for UAT (Coding/Safety/DM etc).
  • Writes specifications for study specific listings, checks, CRF built and authors amendment processes as per study need obeying client SOPs
  • Shares routine metrix to the operational team and follow ups
  • Management of access requests to different users across all functions working on the trial
  • Laboratory setup with external/internal labs, writing specifications, Author Lab agreement (DTA), Laboratory sample and result data reconciliation
  • Performs reviews of online/offline quality checks (Data validation rules) and listings as well as performs quality review of the data.
  • Participate/lead meetings with Client/Vendors being primary face of data management team at study level.
  • Maintains DM documentation in eTMF, performs periodic internal eTMF QC.
  • Oversees work of subordinate DMs, provide on-job trainings, ensures quality of deliverables.
  • Post Go live changes- Initiation of study modification, authors relevant documentation, validation summary reports etc.
  • Periodic Review of CDISC-SDTM conformance check report review.
  • Post DBF CDISC activities - Authors Define XML, Study data reviewers Guide, Finalized Trial Designed Domains specifications
  • Reviews SDTM specifications, Address STAT dry run comments, Identity and fix SDTM related issues in collaboration with SSA.
  • First Point of contact for any queries from sites, CLS related to Laboratory sample flow.
  • Assist in Spotfire Built for Medical review, manage source data.
  • Take responsibility and accountability of Cleaning and other aspects of Interim and final DB lock - SAE memo archival, Coding Report finalization, Cleaning QC, Discrepancies closure, Query management, Lab discrepancies closure, Casebook Freezing, CRF locking, Review listings archival in eTMF etc.
  • Assist in Unblinding (Complete/Partial) of treatment tables, Lab tables etc, Snapshot Requests
  • Protocol Deviation Management - Manages Manual PDs, provide inputs to Programmatic PDs during PD Review meeting.
  • Provides Data management updates in routine study core team meetings, collaborates with different functions for smooth conduct of the trial.
  • Management of Post DBF Data sharing and archival - CRF and Non-CRF data sharing with sites.
  • Management of study specific activities as per study need e.g. ePRO/Watermark specs writing, data transfer agreement, develop specific checks, listings, data review, archival etc.

Clinical Data Associates

Tata Consultancy Services
Mumbai
07.2016 - 12.2019
  • Extensively worked Start-up activities like Writing of validation plan (For SAS checks, edit checks and calculation rules), Testing of edit checks, Data Management Plan preparation, CRF Completion document preparation and keeping track of various post production changes, Study specific data entry guide for Monitors for some trials, Preparation of SAS checks review guidelines for peers, CRF Completion Guideline preparation.
  • Performed Diverse Conduct activities like Check management review (SAS checks), Lab reconciliations (Third party data), Suboptimal responders listing review, Query management (Auto and manual).
  • Parameterization of SAS batches as per DMP, creation of job, generation and review of required listings.
  • Prepare and maintain DMR i.e. Data management report during the conduct phase of study. Keep records of all protocol deviations in DMR, account of elimination codes and records fall under respective codes. Co-ordinated and attended PAM pre-analysis meeting before database release.
  • Form locking (Soft lock) activity for InForm studies.
  • Post Database freezing activities like sharing Non eCRF data, Study center’s data for regulatory submission, CD ROM generation.

Junior Data Analyst

Cognizant
Mumbai
12.2013 - 07.2016
  • Perform Set up activities like UAT of edit checks, DMP preparation, e-Help document preparation and keeping track of various post production changes.
  • Performing conduct activities of Data cleaning through Query management, Edit check listings review, External data recon, SAE recon, Inform Listings review, Data Quality Consistency Checks (DQCC) listings review followed by Freezing/locking of forms as per the study requirement.
  • Perform external data reconciliation like ECG, PK, LAB, IVRS, e-diary, Drug Accountability, Image reconciliation.
  • Perform SAE reconciliation and conducted and co-ordinated SAE meetings to discuss all outstanding issues.
  • Communicate with Site monitors, external data vendors and Safety data analyst to resolve outstanding issues.
  • Perform peer review for data validation activities and proactively assisting fellow team members for the smooth execution of the project.
  • Perform DBL activities as per the Checklist and maintain & Update study related documents. Ensure all casebooks are locked and contact PI for PI signature.
  • Training POC:- Prepare and update training material for new associates and get them approved and conduct their initial trainings and mentoring. Also, Assist associates for training file completion and ensure that the training files are completed and well secured. Maintained locker and entries (For time in and time out) of training files.
  • Worked on transitioned paper studies and performed data entry of scanned paper CRFs/Hard copies of paper CRFs and also performed QC for entered data.
  • Maintained trackers for data entry (Data entry tracker, Issues log, QC tracker) and shared and discussed with client in regular study meetings.

Education

Bachelor in Pharmacy

University of Pune
Pune
07.2007 - 07.2011

Hobbies

I love reading, travel and exploring, Playing chess

Timeline

Study Data Manager

Syneos Health
12.2019 - Current

Clinical Data Associates

Tata Consultancy Services
07.2016 - 12.2019

Junior Data Analyst

Cognizant
12.2013 - 07.2016

Bachelor in Pharmacy

University of Pune
07.2007 - 07.2011

Similar Profiles

CREATE PROFILE
Prashant NighutClinical Data Manager