Yogesh Gupta Pmp

FAQ About Yogesh Gupta Pmp

• What is Yogesh Gupta Pmp's address?

  Yogesh Gupta Pmp is located at
  United States

• What is Yogesh Gupta Pmp's job title?

  Yogesh Gupta Pmp is a
  Professional Experience • 15 years of clinical data management /Standards/operations experience in phases I - IV multi-centric clinical trials . • Clinical Data Standards: Expertise in operational data standards, SDTM standards (SDTM annotated CRF, define.xml/pdf, Reviewer’s Guide, XPT files), Clinical Data Interchange Standards Consortium (CDISC) controlled terminology and validation of eCRT/define packages. • Data Management: Manage CDM team on all CDM activities, including Protocol review and DM inputs CRF design, database development, UAT, IVRS, local lab management, external data handling, SAE reconciliation, medical coding, database lock, data quality control and initiative development. • Project Management: Manage scope of work, budgets, forecasts, timeline, deliverables, milestones, quality, and risks in Data Management, Data Systems, Bio statistics, and Medical Writing, on responsible studies. • Clinical Operations: Review protocol, develop eCRFs/databases, manage sites/vendors, review SAEs, and manage regulatory review and submission. • Cross-Functional Experience: Influence collaborative team contribution in developing protocol, CRF, DMP and providing inputs in SAP and CSR from data management perspective. • CRO and third-party vendor oversight. Implementing strategy and change management at program level. • Certifications- Project Management Professional, Certified Clinical Data Manager, SAS Base Programming for SAS 9 and Six Sigma Green belt. FDA and MHRA GCP Workshop Certificate Therapeutic Experience • Oncology, CAR-T, Gastro-intestinal, Cardio vascular, Infection, CNS, Respiratory, Musculo-Skeletal, Vaccines, Clinical pharmacology, Schizophrenia, Pain, Opioid Use Disorder, Opioid-Dependent with Chronic pain and medical device. Data Systems Experience • Paper CRF: Oracle Clinical, Rave DDE • Standards Tools- Metadata Repository and Pinnacle 21 • EDC: Inform/OCRDC/ Medidata Rave, eCaselink, TrialMaster, Clintrak Bristol Myers Squibb

• What industry does Yogesh Gupta Pmp currently work in?

  Yogesh Gupta Pmp currently works in the
  Bristol Myers Squibb

• What is Yogesh Gupta Pmp's area of expertise?

  Yogesh Gupta Pmp specializes in
  Professional Experience • 15 years of clinical data management /Standards/operations experience in phases I - IV multi-centric clinical trials . • Clinical Data Standards: Expertise in operational data standards, SDTM standards (SDTM annotated CRF, define.xml/pdf, Reviewer’s Guide, XPT files), Clinical Data Interchange Standards Consortium (CDISC) controlled terminology and validation of eCRT/define packages. • Data Management: Manage CDM team on all CDM activities, including Protocol review and DM inputs CRF design, database development, UAT, IVRS, local lab management, external data handling, SAE reconciliation, medical coding, database lock, data quality control and initiative development. • Project Management: Manage scope of work, budgets, forecasts, timeline, deliverables, milestones, quality, and risks in Data Management, Data Systems, Bio statistics, and Medical Writing, on responsible studies. • Clinical Operations: Review protocol, develop eCRFs/databases, manage sites/vendors, review SAEs, and manage regulatory review and submission. • Cross-Functional Experience: Influence collaborative team contribution in developing protocol, CRF, DMP and providing inputs in SAP and CSR from data management perspective. • CRO and third-party vendor oversight. Implementing strategy and change management at program level. • Certifications- Project Management Professional, Certified Clinical Data Manager, SAS Base Programming for SAS 9 and Six Sigma Green belt. FDA and MHRA GCP Workshop Certificate Therapeutic Experience • Oncology, CAR-T, Gastro-intestinal, Cardio vascular, Infection, CNS, Respiratory, Musculo-Skeletal, Vaccines, Clinical pharmacology, Schizophrenia, Pain, Opioid Use Disorder, Opioid-Dependent with Chronic pain and medical device. Data Systems Experience • Paper CRF: Oracle Clinical, Rave DDE • Standards Tools- Metadata Repository and Pinnacle 21 • EDC: Inform/OCRDC/ Medidata Rave, eCaselink, TrialMaster, Clintrak

• Which languages does Yogesh Gupta Pmp speak? 

  Yogesh Gupta Pmp speaks the following languages:
  No languages available.

• Which industries has Yogesh Gupta Pmp previously worked in?   

  Yogesh Gupta Pmp has prior experience in the following industries:
  Celgene , Frontage Laboratories , Glaxo Smithkline , Icon , Cognizant Technology Solutions , Cognizant Technology Solutions , Icon Clinical Research

• What is Yogesh Gupta Pmp’s work experience?  

  Yogesh Gupta Pmp has the following professional experience:
  Bristol Myers Squibb , Celgene , Frontage Laboratories , Glaxo Smithkline , Icon , Cognizant Technology Solutions , Cognizant Technology Solutions , Icon Clinical Research .

• How can I find Yogesh Gupta Pmp on LinkedIn?  

  You can view Yogesh Gupta Pmp’s
  LinkedIn profile at LinkedIn URL.

• What are Yogesh Gupta Pmp’s work email addresses?  

  Yogesh Gupta Pmp’s work email addresses are
  [email protected] .

• What company does Yogesh Gupta Pmp work for?  

  Yogesh Gupta Pmp works at
  Bristol Myers Squibb