Vidhya Ramani Email & Phone Number

Bernards, Nj, Us

Basking Ridge, Nj, Us

Basking Ridge, Nj, Us

Basel, Baselstadt, Ch

Basel, Baselstadt, Ch

An interesting initiative on building a worldwide technology solution for a Global medical enquiry response and knowledge management with best practice guidelines that transform and define the new medical enquiry experience.As a Manager and Global Deployment Coordinator, responsibilities include coordinating the build initiatives and deployment of the worldwide database of global and related country-specific standard responses, FAQs, other materials, and supporting reference documents with integrated medical enquiry tracking and response management to deliver responses by phone, email, fax or post, and self-service website, and with the ability to prioritize and escalate enquiries to appropriate resources regardless of location (e.g., regional, global).

Basel, Baselstadt, Ch

Business and Project Manager of the first in class initiative on a BI enabled data mining tool which can help facilitate publicly available unstructured Clinical Registry information for adding value to business and gaining a competitive edge.

Basel, Baselstadt, Ch

Senior Business and Program Manager of a multi year multi million dollar end to end Clinical Trial Metrics & Dashboarding application implementation for Novartis Phamaceuticals. Successfully implemented the system by working with business teams and subject matter experts of Novartis Clinical Operations (spanning around 32 key senior stakeholders and Users) covering overall Global Development Leadership Team, Global Monitoring, Data Management, Biostatistics & Statistical Research, Clinical Trial Management, Regional and Country heads to identify their organization’s/ Department’s Key Performance indicators and helped in identifying metrics that could be built to measure their KPIs as part of their analytical and reporting needs.

Basel, Baselstadt, Ch

The Clinical Datawarehouse of the Client required a tune up to address business needs and prioritization of changes to suite business' immediate needs. Responsible for business impact analysis of key business needs and defining scope, prioritization, management of changes withing the warehouse ensuring quality and compliance

Basking Ridge, Nj, Us

Refined the existing processes followed by Document Control Centre and interacted with internal functional groups and CROs in terms of transmission and maintenance of Trial Master file (TMF) documents. Designed and Proposed a future state business process and IT Enablement that will be more streamlined across all functional groups and teams as well as with the external CRO vendors which would aid in following a consistent filing structure of documents from all trial teams to enable quicker and accurate submissions to FDA and other regulatory authorities.Guided on SOPs that would require revisions and training that might be required as part of the new process proposed.Solution successully implemented and adopted.

Teaneck, New Jersey, Us

Designed the Business architecture of CDISC-Gateway tool that enables the transition of clinical data hosted in Source database, into CDISC- SDTM compliant output format using a user friendly GUI to perform the mapping of source to target variables allowing various types of mapping logics and supporting choice of multiple SDTM versions for output

Basel, Baselstadt, Ch

Spearheaded the team as a Domain and Functional consultant in providing functional clarity to the requirements of Phase 1 release of the Novartis’ planned eCDMS initiative. Involved in ODM-SDTM conversion activity for the system and imparted domain knowledge on CDISC SDTM standards to team members for performing the activity. Assessed the data model and the domain model to check its compliance with CDISC ODM standards.

Us

The engagement involved building a generic and extensible logical and physical data model to support Development Excellence Metrics defined by Schering Plough Pharmaceuticals. As a Senior Business Consultant and Architect, understood the requirements for Development Excellence Metrics and spearheaded the definition of domain entities and architecting the Domain Model to support Clinical operational reporting around areas of Key Milestones across all Units, Patient Enrollment, Drug Supply, Query Monitoring, Protocol Violations and Dashboards for Site and CRA performance.

Cambridge, Ma, Us

The engagement involved developing a Clinical Data warehouse using ODM and SDTM standards intended to be an integrated repository of clinical data and metadata collected from various data sources and departments. This Clinical Datawarehouse would enable effective management of clinical trials through monitoring of quality and efficiency of the data collected, allow medical review decisions based on safety and efficacy of investigational drugs and statistical analysis within and across studies. As a Business Consultant and Validation Coordinator, Interacted with Client Managers for requirements, prepared and managed the entire requirements around the Clinical Data Warehouse system implementation using CDISC ODM and SDTM standards and also handled the validation aspects of this 21CFR11 compliant application per standards.

As a Project Coordinator, owned the responsibility of planning, managing and implementing migration of around 150 applications from WhiteHouse Station NJ to Charlotte North Carolina. Mentored the team in understanding the applications migrated by interacting with each of the application Subject Matter Experts handling the application across Merck. Devised a strategy of Pre and Post Migration testing of the 150 applications identifying the critical paths and scenarios for testing in agreement with the application heads to ensure that the application continues to run as expected after migration.

Waltham, Ma, Us

The project involveds Clinical Trial development/customization activities in InForm EDC product for Clinical Trials conducted by all top pharma. The process involves customization of various modules in the product. Performed the role of a team lead acting as a technical consultant in the team responsible for estimation, task management, analysis, design, code review and team training on the product and customization activities.

Executive Leadership Program

Health Economics And Outcomes Research

Bachelor Of Engineering, Electronics & Communication Engg