Provide Line Management support for ~20 team members across different departments. Responsible for recruitment activities such as reviewing CVs, candidate interviews, candidate selection process and onboarding new hires, complete end to end process coordinating with Hiring team.Operational Lead for eTMF and Business Project Associates across globally.Operational Lead for Internal – Quality Review Process.Grow eTMF and BPA team to support eTMF filing and Project Management support to LDMs and Account leads. Lead multiple internal department initiatives that has helped in streamlining and improving metrics around Operations.Provide expertise on Clinical Data Management and Risk Based Monitoring studies, escalation support for issue resolution and contingency planning.Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Support in employee appraisal and career growth.

Provide Line Management support for 20 team members across different TA. Responsible for recruitment activities such as reviewing CVs, candidate interviews, candidate selection process and onboarding new hires, complete end to end process coordinating with Hiring team.Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.Provide expertise on Clinical Data Management, escalation support for issue resolution and contingency planning.Lead multiple internal department initiatives that has helped in streamlining and improving metrics around Operations.Operational Lead for Subject Matter Expert Team. Operational Lead for Internal – Quality Review Process

Provide Line Management support for 15 team members. Responsible for recruitment activities such as reviewing CVs, candidate interviews, candidate selection process and onboarding new hires, complete end to end process coordinating with Hiring team.Mentor DM staff across multiple project teams. Ensures that staff fulfill their responsibilities in accordance with company policies, Standard Operating Procedures (SOP), International Council on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines and other relevant regulatory requirements.Manage delivery of projects through full data management study life-cycle. Maintain good communications and working relationships with internal and external stakeholder. Participated in Operational Review meeting with Sponsors.Operational Lead for Subject Matter Expert Team. Operational Lead for Internal – Quality Review Process

Manage a team of 5-10 people. Support both Project Management and People Management. Good people management skills including mentoring, coaching, interviewing, providing feedback and recognition Managed staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee related issues and resolving problems. Manage project timelines, resource projections; identify out of scope work, manage KPI/ SLAs and quality control for the study.

Serve as Senior - Data Operations Coordinator (Sr DOC) for multiple global studies. Manage delivery of projects through full data management study life-cycle. Manage project timelines, resource projections; identify out of scope work, manage KPI/ SLAs and quality control for the study. Maintain good communications and working relationships with internal and external stakeholder.

Perform Data validation (Reviewing, cleaning and processing) of Phase I to Phase IV clinical data on RAVE platform which includes and not limited to Query management process, Listing review, Eye icon review. To perform Database User Acceptance Testing, Edit Checks UAT (creating the test conditions and validating the edit checks for the study); ensuring that the sites updates the data per CRF completion guidelines. To meet data validation with high quality.Also, additional role as Data Operations Coordinator: Responsible for project management of Phase I to Phase IV EDC studies. To provide the clients with monthly metrics update, conduct basic quality control procedures, ensuring that the data management tasks are completed within the turnaround time and coordinating with the Data Entry and Programming teams for the smooth functioning of the study.

Joined IQVIA as Associate Clinical Data Coordinator. Perform Data validation (Reviewing, cleaning and processing) of Phase I to Phase IV clinical data on RAVE platform which includes and not limited to Query management process, Listing review, Eye icon review. To perform Database User Acceptance Testing, Edit Checks UAT (creating the test conditions and validating the edit checks for the study); ensuring that the sites updates the data per CRF completion guidelines. To meet data validation with high quality.

I was part of setting up Clinical Data Management team. I was part of creating SOPs, performing end to end activities, which included Start -up, Conduct and Closeout for Oracle Clinical studies.

We were supporting Symantec - Norton Products Technical Support for APAC region.