Summary
Overview
Work History
Education
Skills
Domainknowledge
Timeline
Generic
Dipendra Ghosh

Dipendra Ghosh

Belle Mead,NJ

Summary

Accomplished IT Professional: Over 20 years of diversified experience in delivering transformative business solutions across R&D and commercial for various industry domains like life science, health care, and oil and gas. Deep knowledge of healthcare enrollment and billing processes (AARP), Clinical Data repository, ISOS and Vocab Labeling, CTMS system, SDTM data structure, Clinical operations and trail provisioning process.

Excelled in managing large-scale projects with budgets exceeding $5M,, ensuring profitability and client satisfaction.

Strategic Leadership & Project Management: Led diverse initiatives including migration of more than 1000 trials from one CTMS system to another system, automation of complex workflow, Honed in leading the product delivery of analytical solutions by extensively utilizing advanced data science and statistical methods for AI, including deep learning methods (convolutional neural nets, generative AI, recurrent neural nets/NLP, and generative adversarial networks).Excels in risk analysis, mitigation planning and optimizing business process for enhanced efficiency.

Client & Stakeholder Management: Known for strong analytical skills and excellent communication, managing relationships with stakeholders/clients and cross functional teams. Ensuring alignment of project/product deliverables with strategic goals and customer’s expectation.

Vendor Management: Familiar with vendor management starting from the selection, negotiation and renewing contracts, controlling costs, reducing vendor related risks, and ensuring flawless service delivery.

Escalations Management: Skilled in escalation management based on the severity. Assigned proper resources, continuously track & monitor progress towards closure and reduce response time and ensure customer satisfaction.

Agile Methodology: With over 10 years of experience in agile methodology practice using scrum scaled agile Framework, kanban framework. Effectively led teams through all stages of project lifecycles. Utilizing Jira effectively to manage agile artifacts and drive towards project success.

Overview

21
21
years of professional experience

Work History

Program Manager

Lummus Digital -TCG Digital Solution LLC
08.2022 - Current
  • Coordinated and led projects, conducting profitability analysis, risk analysis & mitigation planning through RAID log, ensuring successful project outcomes and business value realization
  • Lead twenty members cross functional team to successfully deliver the AI/ML – Generative AI based solution for Oil and Gas industry like MOL group
  • Re-engineered process, effectively managed CR control, budgeting and forecasting activities, enhancing financial efficiency and accuracy
  • Excellent in client handling, relationship management and stakeholder management, fostering strong and productive partnership
  • Conduct a retrospective timely to analyze the area of improvement, how much developed changes are aligned with scope, and the customer's expectations, and in case the expectations mismatch, then immediately engage the product owner or intended stakeholder to mitigate the issue
  • Utilizing interpersonal and diplomatic skills to engage all stakeholders throughout the project and extract the necessary work or get congruence as per the RACI chart
  • Draft and implement program policies with the help of QAG (quality assurance group) and make sure all policies are reflected in the program management plan and all project managers are following the same unless they have a specific reason to tailor an activity
  • Meeting with the customer or project sponsor frequently to understand whether developed products are delivering expected tangible or in tangible benefit
  • Prioritized growth initiatives, ensuring alignment with strategic objectives and maximizing organizational impact

Sr Project Manager- Engagement Lead

United Health Care System (Through CTS)
Horsham, PA
01.2017 - 08.2022
  • Managing offshore and onshore delivery, including resource onboarding, forecasting, budgeting, and change request control.
  • Conduct requirement analysis, feasibility studies, and story points estimation for accurate project planning.
  • Prepared different RAID logs to capture expected and unprecedented events that may occur during the project planning and execution phases, followed by taking it to closure through a continuous tracking and monitoring system.
  • Addressed technical complexities, providing solutions to maintain project momentum
  • Maintained a healthy story burn-down chart by ensuring timely task completion.
  • Led defect triage meetings, resolving issues promptly to maintain project quality
  • Managed escalations (internal and external), ensuring swift resolution and stakeholder satisfaction
  • Prepared & delivered monthly dashboard reports on project progress to top management
  • Conducted audit-related activities and maintained quality metrics to drive continuous improvement
  • Monitored release and sign-off activities, ensuring seamless project transitions
  • Facilitated scrum ceremonies (sprint planning, retrospectives, backlog refinement, daily stand-ups, scrum of scrums)
  • Collaborated with POs, BAs, technical architects, and stakeholders to maintain a healthy product backlog
  • Developed comprehensive test strategies and plans for thorough testing coverage

Project Manager

Merck Sharp & Dohme (Through CTS)
Rahway, NJ
04.2015 - 01.2017
  • My primary responsibility was to make sure that the requirement for migration was captured and validated by the intended stakeholder, and that acceptance criteria and definitions of done were articulated properly, assumptions and risk registers were maintained, and contingency reserves were kept in the overall budget based on the chances of risk occurring.
  • Managing all SDLC processes, such as requirement gathering, impact analysis, and mapping existing traditional curricula, which is required for PI to get access to information about the new curriculum, coordinating with integrating systems like Impact EDC, CTMS, and learning management systems, and making sure they are getting trail and pattern data in time.
  • Stakeholder management is the primary responsibility for the migration project, and from time to time, I seek their advice and congruence by using managerial (diplomatic, interpersonal) skills, and making sure that defined milestones are achieved without any major impediments.
  • Timely running checks and validation of whether project health matrices are under an acceptable deviation limit; if they are above or beyond the limit, then take appropriate action to get the project on track
  • External users of merchandise like PI and internal employees of Merck have different sets of curriculum, and the same is required to get access to the Inform system
  • My role was to make sure that all historical data was properly transferred to the new learning management system, and if new sites opened and the first patient enrolled, then the system should allow PI to access the site in the Inform system and capture patient data through EDC
  • UAT conduction with an accurate sample where most of the inform roles like PI, sub-PI, blinded/unblinded pharmacist, etc
  • Can perform the test and get the expected result
  • Working with major project's stakeholders and presenting them each and every achieved and planned milestone of the project/s on a regular basis and getting their congruence on risk mitigation steps

Subject Matter Expertise

Merck Sharp & Dohme(Through CTS)
Rahway, NJ
10.2007 - 03.2015
  • The Clinical Data Repository (CDR) is the first step toward developing a repository and data warehouse.
  • The Clinical Data Repository (CDR) aims to provide a single data repository for clinical patient data, and to support real-time data loading and processing.
  • Working on project database setup and estimation.
  • The Clinical Operational Reporting Environment (CORE) is a data warehouse for the Clinical Operational process, which is integrated with the Clinical Trial Management System (CTMS), Clinical Data Repository System, Reference Data Repository System, Clinical Trial Planning System, Trial Master File System, learning management system, and Inform EDC.
  • Being a subject matter expert, the following were my responsibilities: making sure dictionary terms and their relationships were accurate according to their verbatim definitions.
  • Study data transformed properly in STDM format, and SDTM views maintain the relationship as per the rule, i.e., the DM view should have patient demographic data, whereas the AE view should have adverse event information.
  • Analyzing data for Vocab and ISOS labeling, and labeling dictionary terms verbatim on their expiration.
  • Provided support for data migration from one CTMS system to another (impact to spectrum), without impacting downstream applications like Inform and the Learning Management System.
  • Built a solution for role-based provision for trial users in EDC, CDA, GLS, MIDAS, and Spider.
  • Making sure trials and the site's information reached Inform-edc, and after patient enrollment and visit, getting data back from Inform.
  • Analyzing the PDAM and SDTM data at regular intervals, and in case information is out of sync, applying the necessary fix by having CTM's congruence.
  • Making sure all clinical relationships are mentioned in the CDA document, and the header and body are generated as per the FDA guidelines.

Developer

Eastern Software System Limited
02.2004 - 05.2007
  • Project: ERP - Implementation

Education

Project Management Professional -

01.2024

Applied Data Science -

MIT
01.2022

Master of Computer Applications -

Dr. A.P.J. Abdul Kalam Technical University
Lucknow
01.2003

Bachelor of Science - Chemistry & Mathematics

Allahabad University
Allahabad
01.2000

Oracle certified - advance PL/SQL 11g

AWS Certified Cloud Practitioner -

Skills

CORE COMPETENCIES TECHNICAL SKILLS DOMAIN KNOWLEDGE

Program, Product & Project management, Agile Methodology Practices, Client Relationship Management, Team building and Leadership, Opportunity Development , Risk Analysis and Mitigation plan, Value based KPI implementation , CR Control Management, Communication Strategy,API implementation strategy, AI/ML or Gen AI based product development

Database – Oracle 9i/10/11g,Oracle PL/SQL, Unix ,Basic understanding of AWS, hands on in Oracle Performance tuning,

Having good understanding of Clinical Data Model, Familiar with Dimension & Fact Tables (Warehouse model) ,Having good analytical skill of Clinical data, Tools – Toad, SQL Navigator, Irwin, GUI – Oracle Forms 6i, Oracle Reports 6i,Unix, Shell Scripting, Python for data Science, Project Management/Quality tools: MIDAS & BMS REMEDY, Team Track, JIRA and Rally

Clinical Operation- CTMS system, having knowledge of integration of CTMS to various downstream system like Inform, Learning management System, Patient Portal, Spider etc, ISOS and VOCAB labeling, Meddra dictionary, SDTM data, Trail processing, Patient enrollment, Significance of various inform roles wrt provisioning,understanding of Reference Information Model(RIM) and CDA ( clinical document architecture), Healthcare enrollment and billing process, Med Supp Part A and Part B plan, Deep knowledge of Petrochemical manufacturing, Retail - vendor fulfillment

Domainknowledge

  • Clinical Operation - CTMS system
  • Integration of CTMS to various downstream systems
  • ISOS and VOCAB labeling
  • Meddra dictionary
  • SDTM data
  • Trial processing
  • Patient enrollment
  • Healthcare enrollment and billing process
  • Med Supp Part A and Part B plan
  • Petrochemical manufacturing
  • Retail - vendor fulfillment

Timeline

Program Manager

Lummus Digital -TCG Digital Solution LLC
08.2022 - Current

Sr Project Manager- Engagement Lead

United Health Care System (Through CTS)
01.2017 - 08.2022

Project Manager

Merck Sharp & Dohme (Through CTS)
04.2015 - 01.2017

Subject Matter Expertise

Merck Sharp & Dohme(Through CTS)
10.2007 - 03.2015

Developer

Eastern Software System Limited
02.2004 - 05.2007

Project Management Professional -

Applied Data Science -

MIT

Master of Computer Applications -

Dr. A.P.J. Abdul Kalam Technical University

Bachelor of Science - Chemistry & Mathematics

Allahabad University

Oracle certified - advance PL/SQL 11g

AWS Certified Cloud Practitioner -

Dipendra Ghosh