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Senior Technical Designer - Rave and Inform EDC

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Fortrea

Oct 24

  • Job
    Full-time
    Senior Level
  • Data
    Research & Development
  • Reading
  • Quick Apply

AI generated summary

  • You need 6+ years in data management/database programming, 4+ years in RAVE/Inform, strong protocol interpretation, technical design skills, and good problem-solving and communication abilities.
  • You will design eCRFs, perform quality control, mentor junior staff, optimize team tasks, ensure compliance, and consult on database development while improving EDC processes and tools.

Requirements

  • 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

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

FAQs

What is the role of a Senior Technical Designer at Fortrea?

The Senior Technical Designer is responsible for leading eCRF design within assigned projects, primarily using EDC tools like Medidata RAVE and Oracle Inform, while also ensuring quality and compliance in database design and development.

Is the position remote or office-based?

The position can be either office-based or home-based and is available anywhere within Europe and South Africa.

What qualifications are required for this role?

Candidates should have a minimum of 6 years of relevant work experience, including 4 years in Medidata RAVE, Oracle Inform, or Veeva. Strong knowledge of the drug development process and clinical data management programming is also required.

Will I have support in my role?

Yes, you will receive support through a strong network, and you will have a personal mentor to guide you during onboarding and throughout your career development.

What types of benefits does Fortrea offer?

Fortrea offers highly competitive compensation packages, including pension contributions, complimentary health insurance plans, remote working allowances, and a genuine work-life balance.

Do I need to be fluent in any specific languages?

Yes, candidates must be fluent in the English language, both verbal and written.

Will I have opportunities for career advancement?

Yes, the role offers opportunities to progress your career as part of a growing and respected global company.

What specific tools and systems should I be familiar with?

Familiarity with Medidata RAVE, Oracle Inform, and Veeva EDC systems, as well as experience in protocol interpretation, database design, and programming, is strongly preferred.

What is the team's approach towards training and development?

The team values mentorship and provides opportunities to mentor junior staff, assist in staff development, and lead training programs to ensure competency standards are met.

Are there any specific responsibilities related to quality control in this role?

Yes, responsibilities include performing quality control procedures for specification development, conducting quality control of study designs, and ensuring compliance with standard objects usage throughout the business.

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Fortrea

Science & Healthcare
Industry
10,001+
Employees
2023
Founded Year

Mission & Purpose

We are creative thinkers with decades of clinical trial experience who drive innovative solutions powered by insights from data and technology. As we tackle challenges in today’s world, we know that we need to be nimble and agile. That’s why we work side-by-side with our partners to eliminate inefficiencies from the process so we can help them deliver life-changing therapies faster for patients, caregivers and healthcare providers worldwide.