As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.
Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.Join our growing team and discover your extraordinary potential by working as a Senior Technical Designer within our division, working with some of our most important sponsors.
The position offers a strong support network, flexible working solutions and the opportunity to progress your career.
This is a permanent, full-time office or home-based role anywhere within Europe and South AfricaIn a client-facing and project management focused role, you will lead eCRF design within the scope of assigned projects.
We are looking for an experienced RAVE database designer who has good specification writing experience.
Experience with Inform/Veeva EDC beneficial.What you can expect from us:Office based or home based anywhere in Europe or South AfricaRewarding and meaningful work in an established, diverse, highly profitable and respected global companyHighly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances etc.A genuine work life balanceFlexibility in working hoursA thorough onboarding with support from your personal mentorA permanent employment contract with Fortrea Drug DevelopmentYour responsibilities:Development and implementation of solutions to global technical service issues and concerns regarding EDC tools like Medidata RAVE and Oracle InformResponsible for designing the eCRF in leading EDC systems including Rave, Veeva, Inform or other EDC systemsResponsible for the preparation and /or review draft and final eCRF, edit check specifications for assigned projects to ensure quality and consistencyFollow attention to detail approach and participate in sponsor meetings and audits/inspectionsAssign tasks and responsibilities to team members, in a manner that: optimizes team capability; delivers timely and accurate results; and supports the needs of the businessAssist Managers in data collection for productivity, Quality, timelines and resource planningResponsible for performing quality control procedures for specification developmentConducts team meetings and provide guidance to Programmers and Data managersResponsible for maintaining study specifications for assigned projectsResponsible for conducting Quality Control of study design for assigned projectsParticipate in the validation of EDC studies when requestedResponsible for the creation and maintenance of library objects within the Global LibrariesResponsible for ensuring compliance of standard objects usage throughout the businessPerform all activities related to specification development for study build and design of databases according to Standard proceduresResponsible for the review and approval of derivations and edit checks requested by the project teamsMentor the study team in CRF Design and specification development for leading EDC databasesOversees the project work of junior staffMentor and aide in staff development, and achievement of competency standardsAssist with the development of training programs to ensure staff, project and technical, achievement of position competenciesPresent training programs to the technical staff regarding study build, standards maintenance, and/or change controlNotify project leadership of requests for out-of-scope work and advise management of changes in scope of projects to enable the timely development of change ordersResponsible for meeting with the data manager on assigned projects to discuss technicalstrategies, contractual obligations and timelines.
Escalate resource needs as appropriateProvide consultation in the area of database design and development with data managersProvide feedback to management on the development potential of staff to assist in staffdevelopmentMaintain awareness of new developments in EDC vendor products which may be applied toimprove the efficient use of these systemsImplement processes as they are refined, or as new processes are developed and initiate andparticipate in the ongoing review of the processes to ensure they are continually improvedYour profile:Good knowledge of drug development process and Clinical Data Management ProgrammingPrevious relevant work experience to include data management and database support: EDC systems programming or SAS programmingYou have previous experience of protocol interpretation skills & building/programming databases in RAVECandidates must be fluent in English language (both verbal and written)Medidata RAVE and protocol interpretation experience strongly preferredTechnical expertise: Design Screens & Program Edits in RAVE and InformGood problem solving skills and a proactive approachGood oral and written communication skillsGood knowledge of clinical trial process and data management, biometrics, and systems applications to support operations preferredAbility to work in a team environmentAbility to work effectively under minimal supervisionAbility to mentor and train the team membersGood time management skills and the ability to work to tight deadlines whilst maintain the highest standards of quality workCandidates must be fluent in English language (both verbal and written).Minimum 6 years of relevant work experience to include data management and/or database programming and spec design activities, including 4 years in Medidata Rave, Oracle Inform, VeevaFortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials.
Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.
Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.