Katalyst Healthcares & Life Sciences is Hiring a Remote Clinical EDC Validation Specialist
Company DescriptionKatalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.Job DescriptionJob Description:7 years of Computer System Validation.Must have 2 years' experience with EDC (Electronic Data Capture) systems and working experience with Medidata RAVE or other major EDC system is a plus.Develop and coordinate tests scripts, testing activities, test plan and reports for database quality validation and/or user acceptance testing to ensure accurate database structure and appropriate data collected.Evaluate data errors and collection issues; provide guidance and recommendations to clinical team for resolution.Provide data management expertise for multiple (multi-site and multi-cohort) projects to bring clinical studies on-line, including leading the testing activities, conducting and administrating test scripts, collecting and documenting test results and reports, monitoring project timelines, and communications to stakeholders.Work collaboratively with Internal team, Data Management, Programmers, Clinical Affairs to meet project deliverables and timelines for data monitoring and reporting.May assist in the study database design and validation activities.May assist in the authoring and execution of validation scripts for clinical reports.Basic project management skills.Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills.Proven expertise in Microsoft Office Suite.Adherence to department SOPs and a regulated environment.Preferred:Medidata Rave SDBE certificationReporting background, Business Objects or BOXIProgramming experience in the pharmaceutical/medical device industry setting.Additional InformationAll your information will be kept confidential according to EEO guidelines.