Shruti Borade

IQVIA Pvt Ltd - Oct 2020

Technosoft Pvt Ltd - Nov 2018 to Sept 2020

• Conduct comprehensive Quality Trial Master File Review in alignment with eSOPs and Guidance documents, improving productivity and ensuring data accuracy.

• Ensure audit and inspection readiness by timely review of eTMF (Core, Country & Site) and maintaining the study-specific system for audit preparedness.
• Perform QC Spot-check and provide feedback to the QC Team.
• Crossfunctional activities with aligned teams for document related queries and resolution.
• Working on Veeva volt and migration work related activities
• FR 2.0 (SIL Review) Member of SIL and Metadata Review where we need to review the
documents and correct, if necessary, changes within timelines.
• Conduct refresher trainings to share study/sponsor specific updates on monthly basis.
• Train team members on records management tasks and manage team priority and allocation.
• Ensure project deadlines, commitments, and goals are met by monitoring project’s daily
outputs
• Ensure all work is conducted in accordance with SOPs, GCPs, applicable regulatory requirements to meet quality and timeline metrics.
• Mentor new team members and conduct QC feedback and knowledge management
session to improve TMF quality.
• Prioritize and complete tasks in a timely manner, yet flexible to multitask when necessary.
• Providing SLA report, team stats of indexing and Review-QC to the management
• Perform complex processes and tasks eventually result in high quality deliverables that are
completed according to service level agreements (SLAs) and within project timelines
• Worked on different platforms like eTMF ELVIS, Wingspan and tools like EEL-C, intelligent
TMF, CTMS, TIBCO Spotfire etc.
• Perform indexing and review QC of the TMF documents for multiple customers Maintain
Tracker for the project specific and customer specific updates.

• Analyses clinical data based on documents provided by CMS, with expertise in ICD9, ICD10, SNOMED, CPT, LOINC, NDC, and HCPCS codes.

• Worked on the GIQuIC registry to build benchmarks for the US healthcare system.

• Utilized FIGmd's MAT (Measure Authoring Tool V4) to create value sets, elements and pseudocodes as per CMS guidelines.

• Conducted clinical data analysis based on cancer genomics, building a database of gene mutation variants.

• Mined clinical trial data from various registries, extracting information on cancer pathways and their correlation in developing different types of cancers.

• Ensured consistent precision in document filing and data management.