Shreya Singh

Experience

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  Sterling Hospital, Ahmedabad

  Jan 2010 - Jan 2013

  Clinical Research Coordinator

  Identification of potential subjects in consultation with the Principal Investigator.Assist in screening, randomization & subsequent subject visits.Schedule subject visits to ensure better subject compliance & retention.Timely completion of CRFs & DCFs.Ensure compliance to protocol, SOP & applicable regulatory requirements.Communicating with the CRO & Sponsor & regular study updates.IP & other study supplies handling, storage & accountability.Communication with the IRB for submission, approval & SAE reporting.Tracking study payments, handling essential documents & site master file & proper archiving of study documents.Coordinate with different departments of the hospital such as pathology, MRD, radiology, nursing etc.Participate in Investigator Meetings & study related teleconferences.Training of other study coordinators, paramedical staff & other site personnel. Show less

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  Cognizant

  Apr 2014 - Nov 2020

  Clinical Team Lead

  Managing end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction. Providing comprehensive data management expertise to Clinical Data Management (CDM) team to provide high-quality data management products that meet customer needs. Providing leadership to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. Performing Data Team Lead (DTL), Complying with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.Client Management: the primary point of contact for customers on data management deliverables. With minimal guidance, provide project management expertise working with customer data managers, key decision-makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise. Show less

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  Tata Consultancy Services

  Dec 2020 - now

  Assistant Manager

  Managing end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction. Providing comprehensive data management expertise to Clinical Data Management (CDM) team to provide high-quality data management products that meet customer needs. Providing leadership to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. Performing Data Team Lead (DTL), Complying with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.Client Management: the primary point of contact for customers on data management deliverables. With minimal guidance, provide project management expertise working with customer data managers, key decision-makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise. Show less