Shraddha Dubey

About Shraddha Dubey

Highly motivated and detail-oriented Clinical Process Associate with 2.5 years of…

Experience

1. Clinical Process Coordinator

   IQVIA

   Jan 2024 — Present · Thane, IN

   Support the clinical study manager in the delivery of clinical study activities in accordance with agreed timelines, budget and quality. Set-up and maintain clinical tracking tools such as CAPRI and the study log, study contact lists, study team training tools, study budget and ESP lists. Organise and participate in meetings e.g, clinical study team (CST) meetings, ESPs. Distribute agendas & generate meeting minutes as applicable. Assist with handling of study related contracts/agreements & CDAs, with e.g, external service providers (ESPs), hospitals and laboratories. Contract management of the study budget including request of purchase orders, invoice processing and tracking, and reporting of monthly accruals. Process documents in relevant electronic document systems e.g, Veeva QMS, DocuSign, internal/external SharePoint sites, Contract POD and Microsoft Teams. Maintain oversight and filing Contribute to the set-up, maintenance and closure of the trial master file (TMF) in collaboration with the TMF Specialists as applicable. Coordinate quality control of study documentation in collaboration with the TMF Specialists, including preparation for internal/external audits, and regulatory inspections. Support updating of clinical studies on clinical trial registries and clinical trial results databases. Set up study Insurance coverage. Coordinate and collaborate with various project stake holders. Review, evaluate and recommend modifications to designated processes 13. Participate in (study) team meetings and implement action items. Collaborate with the project lead/eam members in creation/review ofstudy documents. Setting quality standards and reviewing deliverables to the same for process tasks. Act as SME/mentor/buddy for new joiners and support with system/process trainings. Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines, and project plans with project specific information.

Education

• Guru Nanak Khalsa College of Arts Science & Commerce

  Master of Science - MS, Microbiology, General

• University of Mumbai

  Postgraduate Degree, Microbiology, General

• Guru Nanak Khalsa College of Arts Science & Commerce

  Master of Science - MSc, Microbiology, General

• Lords universal college

  Bachelors of science , Microbiology, General