Medical Doctors

Company: Olesky Associates
Location: Nashua
Posted on: September 13, 2020

Job Description:

Company: Endure Technology Solutions, Inc.

Location: Cambridge

Posted on: August 17, 2020

Job Description:

Validation Lead- Clinical Informatics 6 Month+ Contract The RoleAs a validation leader you will lead the development and executionof compliant and nimble validation strategies for cloud based(SaaS, PaaS) clinical, regulatory and safety applications. Here'sWhat You'll Do Define overall validation strategy and approach forDigital Clinical CSV projects in a digital context (cloud,automation, AI) and in alignment with Moderna QA policies. Authorkey validation documents Validation Plans, Validation Summaryreports, Test Plans etc Advise project and technology teams onvalidation and data integrity best practices and approachesCollaborate with GCP QA on process definition and improvement,author and revise CSV related SOPs Coordinate CSV activities (UAT,document reviews) for clinical digital projects Liaise with GMP CSVteam to harmonize and streamline validation practices Providetraining on Moderna validation process and templates Oversee CSVreadiness for inspections and audits, support QA and business teamduring inspection activities Here's What You'll Bring to the Table10+ years of computerized system validation experience with aprimary focus on GCP, GVP and GLP. 5+ years of validation teamleadership providing coaching and mentoring to CSV engineerstechwriters and coordinating validation efforts within larger projectsProven experience in leading sustainable and nimble validationefforts for SaaSPaaS GxP systems and cloud infrastructure Workingknowledge of CSV, data integrity and ICH guidance related to theuse of computerized systems in clinical trials Experiencesupporting regulatory inspections related to computerized systemsExcellent communication skills Demonstrable experience in authoringkey validation deliverables such as validation plans, validationreports and validation strategy approaches Experience withpaperless validation preferred Knowledge of Veeva, Argus, MedidataRave preferred Bachelor's degree in computer science, biotechnologyengineering or equivalent Regards, Daniel D'Souza TechnicalRecruiter Endure Technology Solutions Cell 617-631-8114 Tel703-574-8651 Fax 703-544-8827 tel703-544-8827 Email mailto

Keywords: Endure Technology Solutions, Inc., Waltham , Validation Lead- Clinical Informatics, Healthcare , Cambridge, Massachusetts

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Keywords: Olesky Associates, Nashua , Medical Doctors, Other , Nashua, New Hampshire