Summary
Overview
Work History
Education
Skills
Therapeutic Experience
Department Specific Experience
Languages
Certification
Declaration
Timeline
Generic

Dinesh Mogili

Homebased

Summary

Providing leadership as well as core and comprehensive data management expertise to a data management team to ensure efficient, quality data management products that meet customer needs and work with the team to ensure high quality data management products to meet customer requirements/expectations.

Overview

11
11
years of professional experience
1
1
Certification

Work History

Trial Data Manager

IQVIA
11.2022 - Current
  • Support in development and testing of data management system edit, data validation checks (diagnostics) and special listings / procedures used as tools for data review and discrepancy management activities
  • Creation of study documents (CCG, ECS, DQPM, PD, DTS)
  • Provide guidance and oversight to vendor partners
  • Collaborates cross-functionally to resolve or escalate data management issues
  • Collaborate with CRAs, Statistical Programmers, Biostatisticians, and project management team to meet data management deliverables and timelines for assigned clinical studies
  • Created dummy data for testing data entry screens and edit checks
  • Participated in relevant operational meetings to identify and incorporate global operational issues into study design
  • Validate data entry screens and edit check programs
  • Support CTMS in coordination of receipt of all ancillary data e.g., safety lab data, analytic lab data, IVRS randomization data to ensure data is received at the time of database lock
  • Organize electronic data loading, run batch validation and generate manual queries in accordance with Standard Operating Procedures
  • Review clinical trial data in accordance with global data management plans and applicable standardized data management processes to identify, missing, incomplete, or implausible data
  • Interact with the dictionary coding and maintenance group to ensure appropriate process set-up
  • Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data
  • Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database
  • Apply quality control procedures and checks to ensure data quality standards are achieved.

Sr. Clin. Data Coordinator

IQVIA, Affiliated Companies
04.2022 - 11.2022
  • Serving as Data Operations Coordinator or Data Team Lead.
  • Manage delivery of projects through full data management study life-cycle.
  • Manage project timelines and quality; determine resource needs; identify out-of-scope work.
  • Perform comprehensive data management tasks including data review, writing and resolving data clarifications.
  • Perform database designer activities for technologies not requiring extensive programming. Test databases, edit specifications and SAS specification.
  • Perform comprehensive quality control procedures.
  • Independently bring project solutions to the CDM team.
  • Solve issues through/using the global issue escalation/communication plan.
  • Consult with Standards Group for process issues; communicate ideas for process improvement.
  • Assist in developing and implementing new technology.
  • Understand and comply with core operating procedures and working instructions.
  • Meet objectives as assigned.
  • Develop and maintain good communications and working relationships with CDM team.
  • Interact with CDM team members to negotiate timelines and responsibilities.
  • Develop and test databases and edit specifications.
  • Perform testing of programming.

Clinical Data Coordinator

IQVIA
02.2021 - 03.2022
  • Manage delivery of projects through full data management study life-cycle
  • Manage project timelines and quality; determine resource needs; identify out-of-scope work
  • Perform comprehensive data management tasks including data review, writing and resolving data clarifications
  • Perform database designer activities for technologies not requiring extensive programming
  • Test databases, edit specifications and SAS specification
  • Perform comprehensive quality control procedures
  • Independently bring project solutions to the CDM team
  • Solve issues through/using the global issue escalation/communication plan
  • Consult with Standards Group for process issues; communicate ideas for process improvement
  • Assist in developing and implementing new technology
  • Understand and comply with core operating procedures and working instructions
  • Meet objectives as assigned
  • Develop and maintain good communications and working relationships with CDM team
  • Interact with CDM team members to negotiate timelines and responsibilities
  • Develop and test databases and edit specifications
  • Perform testing of programming.

Vendor Reconciliation Lead

IQVIA
11.2021 - 03.2022
  • Serving as a Vendor Reconciliation Lead
  • Working on Third Party Data Reconciliation
  • Follow-up on Issues until it's closure
  • DTS updates as per VRL perspective
  • Validation of SAS outputs as per VRL perspective prior to being push to Production and highlight if any issues observed.

Data Reviewer

IQVIA
11.2019 - 04.2021
  • Conduct data review
  • Write and resolve data clarifications and queries
  • Work on Third Party Data Reconciliation
  • Understand and comply with core operating procedures and working instructions
  • Meet objectives as assigned
  • Develop and maintain good communications and working relationships with CDM team.
  • Assisted with database upgrades and migrations by performing user acceptance testing.
  • Exceeded goals through effective task prioritization and great work ethic.
  • Carried out day-to-day duties accurately and efficiently.

Clinical Data Associate - 1

PPD
01.2018 - 10.2019
  • Review and clean data errors for consistency and accuracy according study guidelines and conventions.
  • Perform Site/User Administration to allow access to the database, ensuring all users are qualified to
    access data base
  • Good knowledge of processes and procedures in clinical data management
  • Good knowledge of protocols, DMPs, and SAPs
  • Develops solutions to a variety of problems of basic scope and complexity.
  • Produces project-specific status reports for CDM management and/or clients on a regular basis.
  • Identify, resolve, and update data discrepancies. Makes changes to the data management database as
    required.
  • Review data listings for accuracy and consistency of data. Analyzes and resolves data validation and other data management reports.
  • Perform data management activities such as Serious Adverse Event and Third-Party Vendor reconciliations as well as Data Listing reviews.

Remote Central Monitor I/II

PPD
05.2015 - 12.2017
  • Perform ongoing remote data review, assess for completeness of data and any observed protocol or GCP deviations/violations.
  • Perform event-triggered real-time data review and review of key risk, performance, and quality indicators (KRIs, KPIs, KQIs).
  • Track and assess trending of violations/deviations, enrolment status, and outstanding issues
  • Assist sponsor, study sites, and CRAs with audit preparation/responses and quality issues. Perform ad-hoc clinical listings review.
  • Assisted in the creation of study specific documents and plans (e.g. Communication Plan, Project Plan, Monitoring Plan, etc.), study logs (e.g. Drug Accountability Log, Site Visit Log, etc.), study trackers (e.g. training tracker, FAQ, etc.)
  • Ensure study systems are updated per agreed study conventions (e.g., Clinical Trial Management System – CTMS) to ensure adequate communication to project team and sponsor
  • Liaise with CRA to prompt collection of documents, review of data points, findings from EDC and file reviews, etc.
  • Conduct remote investigations into site performance issues at the directive of the CTM.

Records Management Specialist I/II

Syntel India Pvt Ltd
10.2013 - 04.2015
  • Identification, Processing and Categorization of all the documents generated in Clinical Trial. Quality check of processed documents.
  • Data uploading in Documentum (First Doc) i.e. document repository of client database.
  • Proofreading and final QC of the uploaded documents in repository in order to deliver an error free final product.
  • Maintaining and reconciling Electronic Trial Master Files.
  • Supporting client in Regulatory, IRB/IEC submission, sponsor Audits and other applicable competent authorities Inspections.

Education

Master of Science - Pharmaceutical Sciences

JKK Munirajah College of Pharmacy
Erode
04.2012

Bachelor of Science - Pharmaceutical Sciences

Nethaji Institute of Pharmaceutical Sciences
Warangal
04.2010

Board of Intermediate Education - +2

SR Junior College
Warangal
06.2005

SSC -

Nava Bharath Public High School
Husnabad
03.2003

Skills

  • Experienced in CRF review and tracking
  • Proficient in Database testing, cleaning, lock and discrepancy management
  • Deep understanding of Data validation and verification
  • Knowledge of Good Clinical Practices, ICH and CFR Guidelines
  • Serious Adverse Event (SAE) reconciliation and Batch Validation
  • Experienced in phases I, II and III clinical trials
  • Proficient in Medidata Rave, Oracle Clinical, Inform, J-Review

Therapeutic Experience


Therapeutic Area Experience

Neurology (1.5 Yrs) : Multiple Sclerosis

Oncology ( 6 Yrs): NSCLC, Multiple Myeloma, Prostate, Hepatocellular Carcinoma, Breast Cancer


Department Specific Experience

  • Medidata Rave : >6 Years of Experience
  • Managed Database Lock : 4
  • Discrepancy Review/Query Resolution: >6 year of Experience
  • SAE Reconciliation : >3 years of Experience
  • External Data Reconciliation: >5 years of Experience
  • Database Edit check testing : >3 years of Experience
  • OC RDC: 2 years of Experience

Languages

English
Advanced
C1
Hindi
Upper intermediate
B2
Telugu
Proficient
C2
Telugu
Bilingual or Proficient (C2)

Certification

Registered Pharmacist - 73688/A1. 2012

Declaration

I hereby declare as all the above stated information is genuine & true to my knowledge.
Dinesh Mogili

Timeline

Trial Data Manager

IQVIA
11.2022 - Current

Sr. Clin. Data Coordinator

IQVIA, Affiliated Companies
04.2022 - 11.2022

Vendor Reconciliation Lead

IQVIA
11.2021 - 03.2022

Clinical Data Coordinator

IQVIA
02.2021 - 03.2022

Data Reviewer

IQVIA
11.2019 - 04.2021

Clinical Data Associate - 1

PPD
01.2018 - 10.2019

Remote Central Monitor I/II

PPD
05.2015 - 12.2017

Records Management Specialist I/II

Syntel India Pvt Ltd
10.2013 - 04.2015

Master of Science - Pharmaceutical Sciences

JKK Munirajah College of Pharmacy

Bachelor of Science - Pharmaceutical Sciences

Nethaji Institute of Pharmaceutical Sciences

Board of Intermediate Education - +2

SR Junior College

SSC -

Nava Bharath Public High School

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