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Lead Technical Designer (Database Builder) - Rave and Inform EDC

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Fortrea

22d ago

  • Job
    Full-time
    Senior Level
  • Research & Development
    IT & Cybersecurity
  • Reading

AI generated summary

  • You need 7+ years in data management/database programming, 5+ years in RAVE/Inform, strong problem-solving skills, protocol interpretation experience, and ability to mentor others.
  • You will design eCRFs, oversee project work, mentor staff, ensure quality control, manage specifications, consult on database development, and improve EDC processes while maintaining compliance.

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 7 years of relevant work experience to include data management and/or database programming and spec design activities, including 5 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

Do we support remote work?

Yes, we offer flexible working solutions and provide the option for this role to be home-based anywhere within Europe and South Africa.

What is the main responsibility of the Lead Technical Designer?

The Lead Technical Designer is primarily responsible for leading eCRF design within assigned projects, including the design of databases in EDC systems like Medidata RAVE and Oracle Inform.

What qualifications are required for this position?

A minimum of 7 years of relevant work experience in data management and/or database programming, with at least 5 years in Medidata RAVE, Oracle Inform, or Veeva, along with good knowledge of the drug development process and clinical data management programming.

Is experience with Inform/Veeva EDC necessary?

While experience with Medidata RAVE is strongly preferred, experience with Inform/Veeva EDC is beneficial but not mandatory.

Will there be opportunities for training and personal development?

Yes, the role includes mentoring opportunities and involvement in developing training programs to ensure staff achieve competency standards.

What languages should candidates be fluent in for this position?

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

What type of work environment can I expect?

You can expect a collaborative workspace that encourages personal growth and creativity, aimed at making a meaningful global impact in the clinical trials industry.

Are there methods in place for work-life balance?

Yes, we prioritize a genuine work-life balance, including flexibility in working hours and support for remote working arrangements.

Will I have a support network in this role?

Absolutely, you will have a strong support network, including a personal mentor to assist with your onboarding and career development.

How does Fortrea approach diversity and inclusion?

Fortrea is proud to be an Equal Opportunity Employer and strives for diversity and inclusion in the workforce, ensuring no discrimination based on legally protected characteristics.

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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.