Senior Technical Designer – Medidata RAVE Certified

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🕒 May 1

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Development and implementation of solutions to global technical service issues and concerns regarding EDC tool Medidata RAVE • Responsible for designing the eCRF in leading EDC Rave system • Responsible for the preparation and /or review draft and final eCRF, edit check specifications for assigned projects to ensure quality and consistency • Follow attention to detail approach and participate in sponsor meetings and audits/inspections • Assist Managers in data collection for productivity, Quality, timelines and resource planning • Responsible for performing quality control procedures for specification development • Conducts team meetings and provide guidance to Programmers and Data managers • Participate in the validation of EDC studies when requested • Responsible for the creation and maintenance of library objects within the Global Libraries • Responsible for ensuring compliance of standard objects usage throughout the business • Perform all activities related to specification development for study build and design of databases according to Standard procedures

🎯 Requirements

• Good knowledge of drug development process and Clinical Data Management Programming • You are Medidata Rave EDC Certified Study Builder • Previous experience of protocol interpretation skills & building/programming databases in RAVE • Candidates must be fluent in English language (both verbal and written) • Medidata RAVE and protocol interpretation experience strongly preferred • Technical expertise: Design Screens & Program Edits in RAVE and Inform • Good problem solving skills and a proactive approach • Good oral and written communication skills • Good knowledge of clinical trial process and data management, biometrics, and systems applications to support operations preferred • Minimum 5 years of relevant work experience to include data management and/or database programming and spec design activities

🏖️ Benefits

• Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances etc. • A genuine work life balance • Flexibility in working hours • A thorough onboarding with support from your personal mentor