Neha S. Email & Phone Number

Alameda, California, US

Alameda, California, US

San Carlos, California, US

• Study lead for a global phase 2/3 registrational cell therapy trial that culminated into drug approval
• Led the planning and execution of inspection readiness deliverables (developed storyboards, mock prep, BIMO manual, TMF readiness, training sites, staging, SME) for the lead indication (Melanoma)
• Contributed in BLA preparation for first one-time individualized cell therapy in solid tumors, Amtagvi (Lifileucel).
• Oversaw activities by coordinating & collaborating with the SMT, inspection team and with clinical study teams to set goals and timelines, formulate strategies for execution, and escalate issues as appropriate

San Carlos, California, US

• Led the study team on a global, phase 2 autologous cell therapy trial in cervical cancer
• Responsible for all aspects of registration supporting multi cohort studies expanded over 100 patients
• Managed strategic alliances with CROs & vendors and oversee performance, timelines & business risks
• Led the built of COI/COC systems (released complex study manuals, built training module that was utilized by other studies, scenario planning) for cell therapy trials impacting patient treatment administration
• Recipient of multiple spot awards & recognized by the CEO for operational excellence in study management

San Carlos, California, US

• Led the execution of an autologous cell therapy trial in cervical cancer
• Supervise monitoring of cell therapy administration to patients and logistics of product delivery to hospital
• Contributed to RFP development, bid defense meetings and milestones/KPI tracking
• Led data cleaning efforts for several data cuts and consistently achieved >90% data entry and monitoring objectives
• Receipient of multiple spot awards

Menlo Park, CA, US

• Oversee data management activities including supervising database development, in data cleaning, EDC setup, reviewing and processing data to ensure accuracy and completeness of database
• Key point of contact to lead interactions between vendors on the collection and transfer of data from vendors
• Assess site management effectiveness and evaluate CRO performance per the vendor management plan
• Author/participate in the review of project plans, protocol, CSR development, SOPs and process documents
• Interview candidates and participate in training of new study personnel
• Led the clinical operations meetings to communicate project status/study issues and provide feedback

Menlo Park, CA, US

• NDA Filing for Axillary Hyperhidrosis indication - Key contributor in the planning, preparation and execution of NDA filing - Authored multiple documents and led several initiatives pertaining to modules 1, 2 and 5.
• Inspection Readiness - Manage inspection readiness efforts and provided support in preparation for the BIMO inspection - Identify GCP/compliance risks and developed mitigation strategies/plans to manage those risks.
• Medical writing support during CSR development - Led the effort of incorporating ~500 safety narratives during CSR development of 6 studies in 3 months - Review CSR and ensure deliverables (e.g. appendices) are met per.
• Provide vendor oversight by assessing TMF, in data review meetings, and perform oversight site visits

Menlo Park, CA, US

• Oversee deliverables and timelines for database lock of 5 studies in Phase 3 program
• Led safety management activities by processing AEs, preparing CIOMS, reviewed safety plan, and narratives
• Facilitated in CRO/vendor selection for outsourcing activities and continuous evaluation of their performance
• Liaise with functional groups to coordinate activities during protocol review, CSR review, IP packaging efforts

Berkeley, CA – California, US

• Developed and implemented a randomized behavioral intervention trial, ALIVE-PD
• Developed diet and activity survey research questionnaires (FFQs) e.g. NASA flight ffq
• Performed participation analyses, feature usage and change in endpoints analyses using SAS
• Tracked enrollment activities and performed onsite (SIV and sponsor oversight) visits
• Used markup language to format research questionnaires for electronic display

Iselin, New Jersey, US

• Implemented CDISC SDTM standards
• Reviewed specifications, SAP, mock shells and mapping documents.
• Performed verification of SAS generated reports (TLFs) via independent programming

• Managed case report forms and investigator site filed (ISF)
• Led the study start-up and closeout visits and reported timely updates on protocol deviations
• Coordinated IRB submissions and activities of sponsor personnel during monitoring visits

Master'S Degree, Clinical And Translational Science

Master'S Degree, Biotechnology

Bachelor'S Degree, Biotechnology