- R&D Clinical Development Quality Business Partner- Vendor Quality Oversight and management, Vendor Quality liaison- Process and SOP Development and Compliance- Quality Issue Management- Risk Management

- Inspection readiness Strategy and driving Inspection readiness activities within the R&D business- Inspection metrics, trending, training sites and business, mock inspections- TMF compliance for inspection readiness- Serious Quality issues and GCP Compliance, regulatory reporting and Root cause investigations and CAPA approval and management- Leading the root cause analysis, CAPA approvals and tracking the CAPAs- Data Quality of the acquired assets and integration tasks of the QMS, assessment of the critical risks and mitigation strategies- Risk management at program and study level- Risk analysis and mitigation strategies, communication to Sr. management and tracking of risk scores- Risk based quality management: leading the risk discussions, helping business to identify the risks and mitigation, QTLs and monitoring the risks.- Due diligence for asset acquisitions, review of the QMS, integration strategies - CAPA approval and management of CAPAs from audits, inspections and quality issues in the system- Continuous improvement of the QMS and Clinical Development processes within R&D- Authoring of control documents, procedures- Building bridges between 2 organizations/functions/QMS systems/Data systems

- Main Quality contact for Central study team and US region- Driving Inspection readiness strategy and Health Authority Regulatory inspections (FDA, EMA, Health Canada)- Quality issues management at Study, Regional and Enterprise level and Regulatory reporting of issues as deemed appropriate- Continuous improvement within Clinical Development organization and Quality organization- Authoring of Quality related documents such as Quality manuals, SOPs, Guidances- CAPA approval and management within QMS- Deliver training to the Quality teams and R&D teams

- A global role where I am responsible to manage Regulatory GCP Inspections- The QA point of contact for Issue escalations and GCP deviations- CAPA management and act as QA approver for CAPAs from the business- Quality and Risk management

- Leading the Process Improvements within the Clinical Operations organization- Lead the efforts in defining new processes for Clinical Operation within Data Management, Medical writing etc.- Authoring and updating Process documents such as SOPs, Guidances etc- Providing solutions to the business related to Quality framework- Support to align the processes with the industry standards- Lead and implement the Change Management in the organization- Championing the change management activities within the R&D organization

PROJECT MANAGEMENT ACTIVITIES- Represent the Data management at the Clinical Project team - Responsible for the timely delivery of the validated database for a project for Stat analysis- The main contact point for Data management issues and communications for the project- Understanding the business needs of a study within the project and prioritizing and de-prioritizing the validation according to the needs- Provide timely status to the Project team of the studies and raise any concerns during the meetings- Assessment of the risks to the project from Data management point of view and provide inputs for the risk mitigation plansJOB PROFILE ACTIVITIES- Review of protocol in a timely manner and provide inputs critical from data collection point of view- Critical review of CRF, to ensure all the data points are properly captured in the CRF as per the protocol- Provide inputs to the programmers, data managers in case of issues and taking necessary steps wherever required'- Accountability for the quality of the database and maintaining the highest level of quality- Performing QCs of the database to ensure the database is discrepancy free- Manage the timelines of all the studies within the project and co-ordinate among the sites and project team to ensure all the tasks are completed on agreed timelines- Lead/Part of global task forces for implementation of new processes or tools within the organization and also provide support in trainings and validation of the processes/tools- Mentoring of newcomers in the team-

My job profile involves validation of clinical data including coding of medical terms, reconciliation of lab and SAE data, programming inputs, performing QC on other validations done, hiring activities and other co-ordination activities within the team.

Experience - 4.10 yearsResponsibilities-Extensive experience in handling high priority and complex studies studies ranging from Phase I - Phase IV as well as PMS studies.Handled both Paper and EDC studiesValidation of study specific checks, macros, and listingsRunning of SAS batches and processing and validation of the outputs generatedPosting of queries to the sites, resolving the queries and making appropriate updates in the databasePerform responsibilities of preparing database lock Interaction with the study sites, via telecons CRAs, Monitors, Investigators, Global Study Managers, Statisticians, Scientific writers etc, to resolve the study related issuesResponsible for generating summary reports and listings for the Clinical Department Handle the tasks of supervising and coordinating in various activities of Clinical Data Management services Responsible for providing effective Data Management input to global clinical teams Handle the tasks of providing clinical data management training to new Joinee's and clinical trial team members and external clients Handle responsibilities of coordinating Process ImprovementsInvolved in Lab and Safety reconciliationAn active member of various Global Task Forces within GSKInvolved in Mentoring and training of New CDR'sInvolved in recruitment process, by conducting tests and interviews

Clinical Data Validation, Medical terms coding, reconciliation of Safety and external lab data, query management, interaction with sites, preparation of Data Management reports, Data Management plan