Sharad Soni

Knowledgeable Data Manager bringing 18+ years and thorough, hands-on approach to analysis and handling of data-retention systems. Successful in pinpointing and addressing complex information management flaws. Expert navigation of complex data storage, disposal and security guidelines to maintain compliance with confidentiality mandates. Critical qualitative analytical support and testing to resolve troublesome content access concerns.

• Data Manager, CliniRx Research Pvt Ltd., 07/01/22, Present
• Handling a team of 10 members.
• Involved in study start-up, conduct and close out activities of clinical trials using different databases.
• Performs Case Report Form/Electronic Case Report Form (CRF/eCRF) review.
• Writing/Testing of validation (edit-checks) and discrepancy review.
• Review of Data Management Plan (DMP), Data Validation Plan (DVP), Data Transfer Specification (DTS) and global rulings.
• Performing User Acceptance Testing (UAT) as per study requirements and specifications.
• Compliance with Standard Operating Procedures (SOP), Working Instructions, Regulatory Directives and Study Specific Plans.
• Performs Serious Adverse Event (SAE) and External Data Reconciliation.
• Participates in Internal/External Audits.
• Mentoring of new joinees.
• Holding training sessions for new joinees.
• Performing performance review of team members.
• Preparing Costing/Budgeting for the new studies.
• Reviewing/Updating resource allocation for the studies.
• Reviewing/updating organization’s SOPs.
• Conducting inter-departmental sessions for smooth functionality.
• Database Manager, CliniRx Research Pvt Ltd., 04/01/21, 06/30/22
• Handling a team of 9 members.
• Mentoring and training of new joinees.
• Senior Clinical Data Associate, Syneos Health, 09/01/13, 03/31/21
• Involved in study start-up, conduct and close out of clinical trials using different databases.
• Review of Data Management Plan (DMP), Data Validation Plan (DVP), Self-Evident Corrections (SEC), and global rulings.
• Issuance, receipt and review of Data Clarification Form (DCF) Performs Serious Adverse Event (SAE) and External Data Reconciliation.
• Project Lead/Senior Business Analyst, HCL Technologies Ltd., 04/01/08, 10/31/12
• Assume the project in charge role and responsibilities by performing, assisting, and/or coordinating the data management trial activities in accordance with established procedures.
• Act as a liaison between Clinical Pharmacology group and other groups to a study, providing appropriate coordination and communication.
• Ensure the delivery of accurate, timely and consistent clinical data to support the research.
• Ensure timely completion of tasks and support established departmental objectives.
• Participate in the Study set-up stage of a clinical trial, contributing to the completion of project tasks and review of study documents.
• Ensure quality of data management deliverables.
• Provide input to the development and management of trial project plans.
• Support and monitor data management activities performed by CROs.
• Performing the role of BA and TA in the project.
• Performing UAT (User Acceptance Testing).
• Preparing the periodic reports for the senior management and other related departments.
• Monitoring the progress of each study and suggesting them necessary modifications for further development.
• Training new joinees and team members.
• Clinical Research Offshore Lead, HCL Technologies Ltd., 03/01/06, 04/30/08
• Part of eight-member team involved in the development, testing of protocols using Client's own legacy application.
• Roles and responsibilities include Training team-members.
• Configuration of Protocols.
• Preparing configuration control and management documentation.
• Setting conditions and data validations.
• Creating view definition spreadsheet.
• Performing prep tasks and functional testing.
• Quality Assurance in regard to documentations.
• Analyst, HCL Technologies Ltd., 06/01/05, 02/28/06
• A three-member team was involved in analysis of Health Insurance in US market for HCL as a service provider.
• Team needs to perform SWOT analysis of Health Insurance market.
• Roles and responsibilities include Identify the Structure of Health Insurance Industry in US Market.
• Identify and analyze the present competition in the Market.
• Study the company's strengths, weaknesses, opportunities (growth potential) and threats (competition).
• Research on business operations, company history, major products and services, prospects.
• Analyze the working/functionality of service providers.
• Analyze the feasibility of HCL entry as a service provider in Health Insurance.

• IMedidata RAVE
• OC-RDC
• OC-Paper
• DataLabs

• Cardiovascular - Portal Hypertension, 2 Years
• Cardiovascular - Type 1 Diabetes Mellitus, 1.5 Years
• Endocrinology/Metabolism - Diabetes Mellitus, Type 2, 1 Year
• Hematology - Hemophilia B, 5 Years
• Infectious Disease - Infection, Influenza, 1 Year
• Oncology - Solid Tumors Cancer, 2.5 Years
• Respiratory – Asthma, 2 Years
• Endocrinology – Lipidemia, 1.5 Years
• Vaccines - Streptococcal Pneumonia Infection, 2 Years

• Date of Birth: 12/06/81
• Marital Status: Married