Samantha Knight

Director, Database Programming @TFS HealthScience

Bristol, GB
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jul 2023 — Present

Director, Database Programming @TFS HealthScience

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GB

Leading a team of database programmers located in Europe and the US in the delivery of screen & logic design, integrations and study maintenance (IRT, Lab, CTMS).I am the SME for Rave implementations, also responsible for delivery and maintenance of clinical databases at TFS (TOL and TM). I liaise on a daily basis with multiple cross functional teams (clinical, DM, Stats programming, QA, Finance) and continue to be client facing in study deliveries due to my Rave knowledge. I lead by example from the ground and i\'m always available to troubleshoot and advise as needed. Skills and activities undertaken include- Introduction and implementation of CDISC and SDTM based standards - RFP development and definition of scope change- SOP review and feedback- Resourcing- Recruitment- CAPA and QI contact- System validation (Rave, TOL)- Trained in Medidata Data Surveillance application

SKILLS

21 Cfr Part 11Life SciencesOncologyInformaticsProtocolComputer System ValidationValidationRegulatory AffairsLifesciencesData ManagementSasCRO ManagementClinical TrialsClinical DevelopmentPharmaceutical IndustrySopFdaCROPharmacovigilanceStandard Operating Procedure (Sop)BiotechnologyBusiness ProcessCross-Functional Team LeadershipElectronic Data Capture (Edc)Quality AssuranceGcpSoftware DocumentationSdlcEdcCtmsChange ControlClinical ResearchClinical Data ManagementManagementRegulatory SubmissionsCdisc

ABOUT SAMANTHA KNIGHT

Director, Database Programming at TFS HealthScience

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Samantha Knight — Director, Database Programming at TFS HealthScience in Bristol, GB | Unifers