Experience

Clinscience

• Poland
• Research Services
• 100 - 200 Employee

• Associate Director, Clinical Systems & Integrations

  • Aug 2021 - Present

  Responsible for technical and business project leadership, architecture, and full software development life-cycle (SDLC) of complex health care and clinical trials applications; • Stakeholder of overall data and IT architecture as well as long-term IT portfolio and strategy; • Designed and implemented full-stack Event-based AWS/Azure cloud-based, applications supporting clinical trials and drug safety; • Clinical trial protocol translation to eCRF (EDC); • Leadership and development of eCRFs based on clinical trial protocol (Phase I/II/III); • Provide expert knowledge in eSource application design, integration and development as tool used by Site to conduct clinical trials globally; • EDC development for CRO and SMO based on Medidata Rave and Protocol First and well as in-house EDC and integrations with IWRS; • Integration and data flow leader across CRO and SMO domains focusing on clinical trials; • Knowledge of CDISC, CDASH, SDTM, HL7 FHIR data standards; • Collaborated across SMO and CRO domains enabling global competitive intelligence, knowledge management, and collaboration; • Lead system validation to ensure GxP compliance: Risk based approach based on GAMP5; • Designed and implemented: SRA (System risk assessment), Validation Plan, URS, FS, DS, Test Report, Validation Report, Periodic review,; • Priority point of contact on FDA/MHRA audits; • Author and collaborator of SOPs and WI; • Data Management: DMP, CCG, DTAs, Query management • Full stack development: Angular/React, NodeJS, .NET Core, MongoDB, SQLServer, Azure, AWS, Git, GitHub, BitBucket, CI/CD, REST, SOAP, XML, JSON, Docker. Event driven architecture; Datawarehouse/Delta Marts: Azure DataBricks, Snowflake Show less



Codenamics

• Warszawa, woj. mazowieckie, Polska

• Owner

  • Jul 2017 - Present