Senior Technical Designer

3 semanas atrás

Lisbon, Portugal MAI Fortrea Development Limited Tempo inteiro

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 Africa

In 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 Africa Rewarding and meaningful work in an established, diverse, highly profitable and respected global company 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 A permanent employment contract with Fortrea Drug Development

Your responsibilities:

Development and implementation of solutions to global technical service issues and concerns regarding EDC tools like Medidata RAVE and Oracle Inform Responsible for designing the eCRF in leading EDC systems including Rave, Veeva, Inform or other EDC systems 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 Assign tasks and responsibilities to team members, in a manner that: optimizes team capability; delivers timely and accurate results; and supports the needs of the business 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 Responsible for maintaining study specifications for assigned projects Responsible for conducting Quality Control of study design for assigned projects 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 Responsible for the review and approval of derivations and edit checks requested by the project teams Mentor the study team in CRF Design and specification development for leading EDC databases Oversees the project work of junior staff Mentor and aide in staff development, and achievement of competency standards Assist with the development of training programs to ensure staff, project and technical, achievement of position competencies Present training programs to the technical staff regarding study build, standards maintenance, and/or change control Notify 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 orders Responsible for meeting with the data manager on assigned projects to discuss technical
strategies, contractual obligations and timelines. Escalate resource needs as appropriate Provide consultation in the area of database design and development with data managers Provide feedback to management on the development potential of staff to assist in staff
development Maintain awareness of new developments in EDC vendor products which may be applied to
improve the efficient use of these systems Implement processes as they are refined, or as new processes are developed and initiate and
participate in the ongoing review of the processes to ensure they are continually improved

Your profile:

Good knowledge of drug development process and Clinical Data Management Programming Previous relevant work experience to include data management and database support: EDC systems programming or SAS programming You have 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 Ability to work in a team environment Ability to work effectively under minimal supervision Ability to mentor and train the team members Good time management skills and the ability to work to tight deadlines whilst maintain the highest standards of quality work Candidates 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, Veeva

Fortrea 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.

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