Gopee Shah Dutta

FAQ About Gopee Shah Dutta

• What is Gopee Shah Dutta's address?

  Gopee Shah Dutta is located at
  Regina, Saskatchewan, Canada

• What is Gopee Shah Dutta's job title?

  Gopee Shah Dutta is a
  Clinical Research Specialist with a quality-driven and disciplined approach to completing clinical study targets, management and medical content writing along with regulatory writing in medical devices. 12 years of Clinical Research experience. • Experienced in clinical strategies, trial design and execution for Class-III medical devices. Managing National and International clinical studies for Medical Devices including studies in pilot, pivotal and post market stages. Responsible for project coordination and adherence to project timelines and budget, as appropriate. • Experienced in writing clinical study reports along with data compilation, analysis, literature review and benefit/risk assessment and its interpretation, the reports on Clinical equivalence for medical devices. • Guidelines knowledge: MEDDEV 2.7/1 Rev 4, MDD, EU MDR 2017/745. Experience and knowledge of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support regulatory submissions for CE Marking of new devices and maintaining of CE Mark for existing devices. • Skilled in Clinical Evaluation Reports (CER), SSEDs, Clinical Study Reports, MDR, MEDDEV 2.7/1 Revision 4 (and associated EU directives, regulations, and guidelines), ISO 13485-Medical Devices • My experiences have spanned from study design through study closure. • Leading the Centralized Monitoring team, partner with the project and clinical lead to perform oversight on clinical deliverables for global projects • Coordinating the study start-up, risk assessment through data trending & analytics, development of monitoring strategies including triggers/thresholds, trend analysis of clinical aspects of the trial, share trends and creating an action plan, review, triage and action clinical study alerts and check for operational compliance • Development of study management plans, and/or RBM (risk-based monitoring) specific tools and templates, and/or other study specific plans to evaluate the quality and integrity of the study. Skills and Competencies: • Clinical Operations, Risk-Based Monitoring (RBM), Centralized Monitoring Services, Clinical Trial Management, Clinical Evaluation for Medical Devices Iqvia

• What industry does Gopee Shah Dutta currently work in?

  Gopee Shah Dutta currently works in the
  Iqvia

• What is Gopee Shah Dutta's area of expertise?

  Gopee Shah Dutta specializes in
  Clinical Research Specialist with a quality-driven and disciplined approach to completing clinical study targets, management and medical content writing along with regulatory writing in medical devices. 12 years of Clinical Research experience. • Experienced in clinical strategies, trial design and execution for Class-III medical devices. Managing National and International clinical studies for Medical Devices including studies in pilot, pivotal and post market stages. Responsible for project coordination and adherence to project timelines and budget, as appropriate. • Experienced in writing clinical study reports along with data compilation, analysis, literature review and benefit/risk assessment and its interpretation, the reports on Clinical equivalence for medical devices. • Guidelines knowledge: MEDDEV 2.7/1 Rev 4, MDD, EU MDR 2017/745. Experience and knowledge of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support regulatory submissions for CE Marking of new devices and maintaining of CE Mark for existing devices. • Skilled in Clinical Evaluation Reports (CER), SSEDs, Clinical Study Reports, MDR, MEDDEV 2.7/1 Revision 4 (and associated EU directives, regulations, and guidelines), ISO 13485-Medical Devices • My experiences have spanned from study design through study closure. • Leading the Centralized Monitoring team, partner with the project and clinical lead to perform oversight on clinical deliverables for global projects • Coordinating the study start-up, risk assessment through data trending & analytics, development of monitoring strategies including triggers/thresholds, trend analysis of clinical aspects of the trial, share trends and creating an action plan, review, triage and action clinical study alerts and check for operational compliance • Development of study management plans, and/or RBM (risk-based monitoring) specific tools and templates, and/or other study specific plans to evaluate the quality and integrity of the study. Skills and Competencies: • Clinical Operations, Risk-Based Monitoring (RBM), Centralized Monitoring Services, Clinical Trial Management, Clinical Evaluation for Medical Devices

• Which languages does Gopee Shah Dutta speak? 

  Gopee Shah Dutta speaks the following languages:
  No languages available.

• Which industries has Gopee Shah Dutta previously worked in?   

  Gopee Shah Dutta has prior experience in the following industries:
  Iqvia , Meril , Concept Medical , Concept Medical , Envision Scientific Pvt Ltd And Concept Medical , Global Drug Development Experts , Cognizant Technology Solutions , Concept Clinical Services Surat , Life Care Institute Of Medical Sciences And Research

• What is Gopee Shah Dutta’s work experience?  

  Gopee Shah Dutta has the following professional experience:
  Iqvia , Iqvia , Meril , Concept Medical , Concept Medical , Envision Scientific Pvt Ltd And Concept Medical , Global Drug Development Experts , Cognizant Technology Solutions , Concept Clinical Services Surat , Life Care Institute Of Medical Sciences And Research .

• How can I find Gopee Shah Dutta on LinkedIn?  

  You can view Gopee Shah Dutta’s
  LinkedIn profile at LinkedIn URL.

• What are Gopee Shah Dutta’s work email addresses?  

  Gopee Shah Dutta’s work email addresses are
  [email protected] .

• What company does Gopee Shah Dutta work for?  

  Gopee Shah Dutta works at
  Iqvia