Management Project

YOGESH KUMAR GUPTA

Phone 848-***-**** ******@*****.*** ***********@*****.***

SUMMARY: Project Management Professional (PMP), Project Management Institute (PMI) India Champion, Certified Clinical Data Manager (CCDM 2011-2014), Six Sigma Green Belt (SSGB) professional with 8 years of experience in clinical data management. Expertise in project management, Hands on Clinical database set up (Medidata Rave, Inform, Oracle Clinical, OCRDC), study conduct and close out activities, Clinical Trial Management System (CTMS) tool design, development and SOP creation, continuous improvement of operational processes and standards, eTMF, productivity and efficiency improvement, vendor management, CRO oversight, leadership, strategy and change management, CAPA, transition, business development, defense bid, request for proposal, compliance, trainings, hiring and resource planning and allocation. Knowledge of FDA regulations, GCP, GCDMP and ICH guidelines. Drive global programs and million dollar projects from end-to-end, with focus on building corporate competencies, bottom line gains and providing strategic direction. Performed hands on data management activities for Pfizer, Eli Lilly, AstraZeneca, Novartis and GSK.

EXPERIENCE

Frontage Laboratories Inc Jul 2016- till date

Senior Data Manager New Jersey, USA

Lead and oversee all DM activities including interim and/or final database locks inclusive of interacting with the appropriate cross-functional staff: biostatistics and programming.

Performs hands on and manage the development and validation EDC study builds and the associated data listings, reports, data transfers and detailed timelines.

Defining CRF standards, oversee individual study CRF design and production. Also author Data Management Plans (DMP) and CRF completion manuals

Monitor data management workflow and tracks project metrics for task completion

Responsible for project management to ensure that all data management goals are met within clinical and project teams.

Involved in developing and tracking metrics on productivity and quality and creates strategies and best practices to increase efficiency.

Develop and maintain project level standards for data collection and data handling

Participate in selection of data management EDC vendors and ensure quality and performance of vendors

Regularly interacts with dictionary coding personnel to ensure appropriate process set-up and application.

Involved in mentoring, developing a team of direct reportees and providing guidance and direction to ensure departmental and client/project goals are met.

Overseeing and reviewing clinical trial data to identify erroneous, missing, incomplete, or implausible data.

Contribute ways to continuously improve all aspects of DM; implements solutions.

Glaxo Smithkline Pvt Ltd Sep 2015- May 2016

Project Data Manager Bangalore

Leading and managing DM tasks outsourced to external vendors and ensured that milestones, deliverables, quality and timelines are met within budget and in accordance with regulatory requirements.

Executed plans according to the DM Outsourcing and related strategies and processes.

Developed positive partnerships with CROs and ensure a high standard of deliverables are maintained.

Involved in collaborating, communicating, coordination and prioritization within the department.

Routinely monitors project activities to ensure quality and timelines within budget and assists with identifying changes in project scope or efficiencies to maintain budget.

Represents Data Management and facilitates project related integration with other groups, notably Data Operations, Clinical Research, Clinical Programming, Statistics and Regulatory.

Helps in Preparing and maintaining timelines and resource plans for the assigned studies, and communicates to management any timeline or resource issues so that appropriate actions can be taken.

Primarily responsible in collecting and monitoring study metrics and works with Strategy group to monitor and potentially improve departmental metrics.

Attends or coordinates virtual investigators’ meetings; gives input into the presentations that involve relevant data management topics; oversees presentations delivered by service providers or gives presentations.

Involved in oversight and performing UAT on CDMS components as needed.

Initiates efforts for improving current processes for better efficiency and faster turn-around.

Supports the department development of SOPs, procedural documentation and process improvement.

Playing key role in the evaluation, validation, and implementation of software and of new data management technologies.

Led capability assessments of Biometrics vendors including CROs and 3rd Party Vendors

Involved in Inspection and Provided support to Biometrics staff with quality activities including CAPAs and process deviations

ICON CLINICAL RESEARCH Jan 15 – Sep 2015

Clinical Data Lead – Clinical Data Management Chennai

Coordinating and developing team capability and assisting with the management of the day to day activities of data management.

Involved in delivering projects to quality, timeline and budget requirements.

Managing resources and costs through monthly forecasting and revenue recognition.

Assist in maintaining and developing processes and systems.

Develop and foster sponsor relationship

Provide regular status report and KPIs to senior management and represent Data Management at oversight meetings.

Drive process change to facilitate efficient Data Management performance.

Actively participate in business development opportunities as required.

On standalone projects studies provide Project management support to other functions as required.

Principal Data management contact for project team both internally and with sponsor.

Involved in Study set up activities like CRF design and creation, Data validation specification, Data Extraction specification, CRF completions guidelines, Data management Plan, Screen UAT, System UAT, Report specification and Data transfer Specification.

COGNIZANT TECHNOLOGY SOLUTIONS Feb 10 – Dec 14

Team Leader/ Lead Data Manager – Clinical Data Management Mumbai

Leading a team of 25 associates for end-to-end data management of projects. Responsible for database setup, documentation, process improvements, compliances, risk management, approvals, quality, training and team development for different therapeutic areas like cardio vascular, gastro intestinal, infection, metabolic, oncology & respiratory in individual and leadership capacities.

Managing various projects for testing safety and efficacy of new molecule/compounds in human trials; involved in entire life cycle from concept of drug to final approval from FDA/EMA/JRA

Engaged in formulating project plan and blue print including defining roles, responsibilities, risk analysis and more for delivery of same as per stakeholder expectations

Involved in executing design, documentation, testing, and implementation of data collection systems and processes in support of clinical study teams

Ensuring completion of all activities like coordination of data management & review activities, clinical study team data reviews and others for reaching goal of Study Database Lock

Project Management

Involved in directing and managing project development from beginning to end.

Creates and executes project work plans and revises as appropriate to meet changing needs and requirements.

Develop accurate resource planning estimates to effectively manage personal workload and maximize individual productivity and revenue generation.

Define project scope, goals and deliverables that support business goals in collaboration with senior management.

Develop Project Plans and Schedules that represent the appropriate level of detail and task interdependency.

Develop and document high-level strategies for achieving specific objectives or activities (hierarchical strategy, process flow, Final Project Summary, etc.).

Manage change and/or conflict within any project in an effective, timely, and appropriate manner.

Leading (coordinate, facilitate, and motivate) the efforts of the individual, team, client, and other resources associated with project activity.

Focus to outstanding customer service principles interacting with clients and coworkers.

Leading, coordinating, facilitating, and motivating all associated project resources to gain alignment on project goals and deliverables.

Leading risk management within project teams, ensuring risks have appropriate mitigation and contingency plans.

Reviews deliverables prepared by team before passing to client.

Effectively applies PMI methodology and enforces project standards.

Prepares for engagement reviews and quality assurance procedures.

Ensures project documents are complete, current, and stored appropriately.

Creates Service orders for any new studies and any Nonstandard work.

Determine and assess need for additional staff and/or consultants and make the appropriate recruitments if necessary during project cycle.

Identify and manage project dependencies and critical path.

Develop and deliver progress reports, proposals, requirements documentation, and presentations including dashboards during milestones to track the real picture.

Define project success criteria and disseminate them to involved parties throughout project life cycle.

Operational Initiatives

Introduced concept of integrating third party vendor data with global library for customizing Rave modules and optimized TAT of reviews and approvals

Integrated edit check automation tool with global clinical data management software for easy access to relevant information and savings in terms of time and efforts

Participated in green & black belt projects for reducing changes in PPC and for database migration leading to cost control and savings in terms of manpower and time

Pioneered HLR (high level result) analysis successfully in company during conduct phase of trial; faced challenge of executing same without any previous empirical cases/documentation

Resolved issues of discrepancies faced due to change in vendors during database lock of a trial; provided options acceptable by sponsor & vendor leading to cost & time savings

Database Set Up

Led database set up activities like creating Data Standard Documents(DSD),Visit Matrix, eCRFs & Data Validation Specification (DVS), Data Extraction specification (DES) & IVRS addendum/SOWs and related documents

Faced challenge of building specification for 5 critical modules in set timeline for gastro intestinal study as same was not available at clients global library; received appreciation for same

Process Improvements

Faced challenge of restoring live data base access to users during conduct phase of study due to automatic system revoking of same

Defined and mapped process for identifying duplication of documentation; reduced time taken for processing to 5 days per study

Reduced number of PPC (post production changes) from 8 to 1 per study for improving the productivity & cycle time of a study

Automated Clean Patient tracker for monitoring cleaning status of per subject per visit during critical milestones of study and provided visibility to stakeholders for building trust in study

Facilitated development of edit check automated tool for reducing DVS (data validation specification), minimized error/review time & eliminated need of creating global edit checks

Contributed towards revamping of global edit checks for cardio vascular & gastro intestinal therapeutic areas leading to streamlining of global library

Spearheaded implementation of Rave DDE tools used in collection of paper clinical trials; customized and automated same in alignment with end user requirements

Operational Efficiencies

Involved in preparation of RFPs for acquiring new sponsors; participated in defense bid for new clients as a SME

Contributing to preparation of SDC (study design concept) and protocols related to data management for identifying defects or absence of relevant items during initial phases of a study

Evaluating CRO proposals & contracts and project invoices; recommending cost optimization measures related to data management tasks and inclusion of any additional NSW charges

Reviewing sponsor contracts and ensuring out-of-scope tasks are charged as NSW (nonstandard work) to client; initiated change order processes for same

Identified ELISA TEST ASSAY was not defined in clinical protocol and recommended same be charged as addition in scope to client

Conducted brainstorming sessions, collected, validated and processed data and performed UAT for authenticating the Rave DDE tools; prepared SOPs & imparted training on same

Created & validated programmed edit checks and test scripts; developed Data Transfer Specification (DTS) for collecting third party data from Lab, PK & Biomarker

Involved in IVRS information gathering, Vendor meetings, UAT, Documentation, trouble shoot and maintenance.

Executing quality control activities during critical milestones for ensuring zero discrepancy in database and nil delays in delivery of study timelines & deliverables

Prepared change requests & closure forms for studies requiring database modification due to protocol amendments or migrations; performed 25+ Rave database migrations

Liaising with clients for presenting on SLA/KPIs and any other challenges or risk mitigation issues relevant to a specific project

Compliances, Approvals & Documentation

Ensuring 100% compliance with quality standards, SOPs, ICH-GCP & other local regulations

Ensuring maintenance of proper documentation; reviewing & approving CRO DM documents in alignment with regulatory data submission & study protocol guidelines

Ensuring clinical data captured is as per study protocols in terms of accuracy & consistency and data submission is as per regulatory authorities like FDA/EMEA

Reviews, Trainings & Team Management

Conducting process & CDMS tool specific trainings for each new clinical study; provided online training through Webex to stakeholders on data management

Provided on-the-job training on “study set up” to team of 5; acted as TA (therapeutic area) Guru for cardio vascular & gastro intestinal and created training DECKs for new recruits

Authored process document “A Self Help for LDM” (Lead Data Managers)

Provided On job RECIST (Response Evaluation Criteria for Solid Tumor) training.

ICON CLINICAL RESEARCH Aug 08 – Feb 10

Clinical Data Associate - I Chennai

Performed data cleaning & set up activities for entire life cycle of study; participated in EDC and paper studies in therapeutic areas like oncology, diabetes, schizophrenia and many more

Engaged in data validation for metabolism and nutritional disorder, rheumatoid arthritis, obstetrics & gynecological disorders

EDUCATION

International Masters of Business Administration– Information Technology United Business Institutes (UBI), Belgium

Post Graduate Diploma in Clinical Research & Regulatory Affairs

Nucleus Institute of Global Education affiliated to Birmingham College, UK Pune

CERTIFICATION, TRAININGS and SEMINARS

Project Management Professional (PMP- 1615097)

Certified Clinical Data Manager (CCDM- 2011-2014)

PMI India Champion (2012- till date)

Medidata Rave Study Design, build and Essential trained.

Six Sigma Green Belt from Cognizant

Skills and Core Competencies

CDMS Tools - Oracle Clinical, Oracle Clinical Remote data Capture, Medidata Rave, Rave Double Data Entry (DDE), Inform, Clintrak, eCaselink, J-review and Microsoft Project Plan. Working knowledge of SAS.

Process streamlining, standardization, Six sigma- RCA, CAPA and Lean six sigma

Line management, People management includes Resource Planning, Hiring, Team building, Training & development, Defining KRAs, Work allocation, Compliance to standard procedures & guidelines, Performance review & feedback, Rewards & recognition.

Functioned in the Data Management department for different Phases I-IV of Clinical Trials in different Therapeutic areas like – Respiratory, CNS, Infection, Ophthalmology, Oncology and Cardio-Vascular, Metabolic and Musculoskeletal, Vaccines, Epidemiology, (Rota, Flu, Pertussis and Dengue).

Contributed to the CDM projects throughout their entire life cycle right from RFP preparation to proposal evaluation & vendor finalization and from study set-up to database lock.

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