Neha Tanwani

Experience

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  PreventiNe Life Care Pvt. Ltd.

  Mar 2011 - Mar 2013

  Assistant Key Account Manager

  -Sending genetic test results as a customized laboratory reports to clinicians -Resolving various queries by Clinicians, Clients, and Parents as applicable. -Contribution in laboratory operations and documentation by providing inputs in different departments. -Serving as a liaison between the laboratory and clinicians/clients.

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  Vasta Global

  Apr 2014 - Aug 2017

  Senior Clinical Research Associate

  Involved in clinical data management for Cancer trials being conducted in US centers. Clinical Data Management:-Discrepancy Management in EDCs (Rave, Oracle, Inform, etc) for ongoing trials-Perform data management activities for the assigned projects in a timely and efficient manner.-Ensure completeness and submission of data by team members as required.-Provide day to day support with respect to data entry from electronic medical records into sponsor databases. -Ensuring quality of the clinical data with EDC for the assigned trials.-Participate in conference calls and meetings with clients to discuss the progress of trials.-Conducting trainings for the new employeesClinical Operations: -Monitoring and tracking patient visits as required for follow-up.-Coordinating with clinical staff to ensure all study procedures/tests with patients are scheduled and completed for different trials.-Review source documentation for disease progression, treatments and medications for cancer and any other data required for submission to sponsors.-Completion/submission of Trial specific Case Report forms (CRF/e‐CRF) for various clinical trials using patient’s source records.-Regulatory submissions (Continuing review reports, Safety Reports, Protocol Amendments, Violations etc) for continuing approval of trials.-Tracking patients for adverse events.-Updating/managing Clinical Research database and other applications as applicable.-Resolving queries from sponsors.-Study Closure documentation.-Performing regular self audits to see data is completed and accurate per regulations.-Assisting Principal Investigators for documentation as applicable.-Administrative tasks and updates. Show less

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  Tata Consultancy Services

  Sept 2017 - now

  Clinical Trial Master file (eTMF ) specialist

  Working as eTMF (electronic trial master file) analyst- providing support to the global R&D trials of different therapeutic areas. -Maintain the quality of study trial master file as per SOPs and GCP/ICH guidelines and ensuring submission and inspection readiness of TMF at all times. -Assist with eTMF reconciliation by uploading documents/missing documents in pharma TMF as per the standard requirements. -Archiving of essential documents as per sponsor TMF SOP.-Performing periodic quality checks of (e)Trial master file to identify any issues to ensure TMF meets internal and external quality standards.-Support trial management teams in the internal and external audits.-Assist in development of project timelines.-Administrative tasks and updates. Show less