Neetu Singh
Senior Tmf Quality Specialist @Premier Research
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WORK HISTORY
Senior Tmf Quality Specialist @Premier Research
Gurugram, IN
Performs quality reviews of TMF content; metadata; study specific process documents;eTMF system reporting; KPI dashboards, etc. to ensure compliance.• May perform quality reviews at the Sponsor program level.• May perform quality reviews using Sponsor eTMF systems.• Provides audit and inspection readiness preparation and support.• Assists TMF Leads with ensuring readiness of TMFs for final transfer.• Ensures tracking and reporting of all quality review activities is being performed.• Performs data collection, analysis and reporting of TMF quality key performance indicatorsas needed.• Works directly with TMF Leads, Project Teams and Quality Assurance on identifying qualitytrends, determining root causes and implementing corrective and preventative actions.• Performs all department budgeted activities for assigned studies and providesresolution/guidance on discrepancies.• Assists with all other Global Records Management tasks as required.
EDUCATION
V.B.S Purvanchal University
Bachelor's degree, Biotechnology
Allahabad Agricultural Institute
Master's degree, Bioinformatics
Holy Cross School, CBSE Board
10th, Science
Holy Cross School, CBSE Board
10+2, Biology, General
PES University
P G Diploma, Clinical Research & Clinical Data Management
ABOUT NEETU SINGH
A dynamic Quality Assurance, Regulatory Affairs, Clinical Trials & Clinical Research professional having 10 years’ extensive experience in highly reputed clinical research Organizations like PPD, GSK and Rakuten Medical. • Earlier I worked for Rakuten Medical as a “GCP Quality Specialist” in Berlin, Germany.• Worked as “Regulatory Associate Manager in world renowned pharma company GSK (GlaxoSmithKline) Bangalore, India.• Previously worked as Senior Clinical Trial Coordinator in PPD India Pvt. Ltd (a global CRO), Bangalore.• 10 years extensive hands-on experience in Quality, Regulatory Affairs Operations & Clinical Trial Operations using Veeva eTMF and Regulatory Veeva Vault. • Hands on experience on Veeva RIM Systems to perform EU Submissions - PIP, CTA, MAA, EU Procedures - NP, MRP, CP, US Submissions- IND, NDA, BLA.• Hands on experience in both Pharma and Vaccine products clinical trial and submission.• Hands on working experience on Oncology, Immunology and Infectious diseases therapeutic areas.• 1.5 years of experience in provisioning of primary support to end users of RIM systems and processes to enable efficient ways of working including provide basic guidance, ad-hoc training, attendance at group meetings, provision of appropriate Reports etc.• 5 years’ experience in handling several clinical projects from startup to closeout phases phases (Phase 1, Phase 2, Phase 3 and Phase 4) in clinical domain. • Worked on several tools for different activities such as Gap Analysis, Training compliance tracker, eTMF completeness and eTMF Compliance trackers.Regulatory & Clinical Research Skills:• CAPA (Corrective and Preventive Action), Clinical Administration, regulatory documentation, clinical monitoring, regulatory submissions, project management by using ARENA System and M-Files.• Expertise in Regulatory Information Management Systems and processes in-use within Global Regulatory Affairs.• Clinical Trials — Startup to maintenance phase.• Clinical Administration, regulatory documentation, clinical monitoring, regulatory submissions, project management.• Site initiation, site activation, study startup and feasibility.• ICH GCP guidelines, US (FDA) Tools:• CAPA, Quality Events Management Tools: ARENA System, M-Files• Document Management: Veeva Reg.Vault, Opal, CTMS, Veeva eTMF• Dashboard Report: Preclarus, Pivot Table• Access Management: IWRS, Medidata-Rave, ePIP, Firecrest, IRT, ERT, DrugDev, Sponsor View, Lab portal• File Review: OBI (Oracle Business Intelligence)• SOP/WPD: RPA SOP submission tool
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