Lead requirements gathering efforts and translate Business Requirements into Functional/Technical Specifications.
Develop the necessary documentations for IT solutions delivery, working closely with Project Managers (e.g. Statement of Work, Project Objectives, Use Cases, Stakeholder Requirements, Functional Requirements, Transition Requirements, Training Documents, etc.).
Carry out Source System Analysis, including Data Profiling & Data Quality Analysis, for the Clinical system (EDC, CTMS, Argus, LIMS, Global Safety Warehouse, CRO data, SAS datasets etc)
Experience in building out Exception Handling process & Business rules for each of the source systems
Develop Mapping Documents for integrating data from the source systems into a Common Data model (based on CDISC standards like SDTM, SEND, ODM etc)
Generate Test Plan, Use Case Scenarios, Test Cases, and conduct User Acceptance Testing with business partners.
Assist in product solution identification, evaluation, selection, implementation, testing, and working with the IT Delivery Team(s) in delivering the business requirements.
Draw out key business insights and provide actionable recommendations.
Interface with business and functional teams providing strong analytical and problem solving skills.
Work closely with the IT platform leads to apply standards and evolve process to ensure solutions abide by best practices and industry principles.
10+ years minimum experience in the Information Technology field.
5+ years of working in Bio-Tech/Bio-Pharmaceutical Industry supporting R&D
Strong knowledge of processes and applications related to Clinical Operations, Medical Affairs, Clinical Data Management, Clinical Science, Biostatistics, and Drug Safety & Pharmacovigilance (e.g. Oracle Argus, BioClinica, CTMS, JReview, SAS, etc.).
Knowledge of procedures and best practices related to FDA, EMA, GxP, CFR21 Part 11, Computer System Validation, Sunshine Act, HCP Transparency Reporting, and other regulations governing drug development and commercialization.
ctms, edc, cro, argus, sas, clinical
Saama Technologies, Inc.