Simran Bhatia Email & Phone Number

Charlotte, Nc, Us

Designed tailored eCOA software solutions leveraging product portfolio with the study protocol for 20+ clinical trials delivering real-time, patient-reported outcome data aligned with regulatory guidelines and industry standardsReduced requirement bugs by 70% by managing detailed design requirements in JIRA through user stories and functional specificationsLed project kick-off and design meetings as primary requirement gatherer with internal and externalstakeholders to translate business requirements, develop well-architected solutions, and offer alternative design solutions balancing client feedback with product capabilities and limitationsCollaborated with 5+ pharmaceutical industry partners and cross-functional teams, resulting in 85% on-time delivery within scoped project timelines and budget allocationsAnalyzed and managed design risks by conducting thorough risk assessments, identifying potentialchallenges and limitations, and implementing strategic mitigation plansDeveloped innovative eCOA technologies to enhance user experience and data integrity, collaborating with product management and regulatory authorities

Assisted with the development, review, and submission of study-related documentation, monitoring, auditing, recording, and reporting throughout 4 phases of a clinical trial (ICFs, CRFs, SOPs, monitoring plans, study, etc.) as per ICH-GCP and regulatory requirements Subject Matter Expertise of GCP standards in the conduct of clinical trials in data recording, handling, and storage in relation to communication with the Investigator, Sponsor, CRO, IEC, and Regulatory Authorities

Assisted with the development, review, and submission of study-related documentation, monitoring,auditing, recording, and reporting throughout 4 phases of a clinical trial (ICFs, CRFs, SOPs, monitoring plans, study, etc.) as per ICH-GCP and regulatory requirementsSubject Matter Expertise of GCP standards in the conduct of clinical trials in data recording, handling, and storage in relation to communication with the Investigator, Sponsor, CRO, IEC, and Regulatory Authorities

Wake Forest, North Carolina, United States

Designed, planned, and implemented cloud solutions for 100 users delivered infrastructure, network, and storageConfigured highly available and scalable multi-tier architecture including VPC, S3 storage, and EC2 instances to ensure high availability, resilience, and dynamic scalability for supporting test, non-prod, and prod environments.

Durham, North Carolina, United States

Worked alongside retail representatives to boost sales by enhancing product presentations, and excellent customer service. Managed and maintained proper signage according to new promotions and pricing.Resolved customer issues and complaints to strengthen store reputation.Assisted an average of 40 customers per day in selecting items and provided recommendations as per customers’ requirements to increase customer experience.Ensured to stay up to date on product knowledge and training material.

Durham, North Carolina, United States

Closed over $1,000 in sales during each month, including preparing contracts, and processing order forms. Organized store display to keep visual appeal, engage customers and promote products. Facilitated inventory audits and stock management to assist the department manager and store and replenish stock.