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Senior Technical Designer - Rave and Inform EDC

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Fortrea

9d ago

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

AI generated summary

  • You need a degree in life sciences or IT, 6+ years in data management, 4+ in EDC (RAVE/Inform/Vault), excellent communication, leadership skills, and knowledge of clinical trials.
  • You will design eCRFs, review specifications, mentor staff, ensure quality control, participate in meetings, manage project scope, and maintain compliance with regulations and procedures.

Requirements

  • University / college degree (life sciences, health sciences, information technology or related subjects preferred).
  • Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor's degree.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
  • Fluent in English, both written and verbal.
  • 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 Vault or equivalent EDC experience.
  • Demonstrate excellent problem-solving skills, a proactive approach and the ability to make sound decisions.
  • Demonstrated skill in leading teams, by example and mentoring staff.
  • Excellent oral and written communication and presentation skills.
  • Knowledge of clinical trial process and data management, CRF/eCRF Design, CDISC.
  • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
  • Demonstrated ability to work in a team environment.
  • Demonstrated ability to handle multiple competing priorities.
  • Proven interpersonal skills.
  • University / college degree (life sciences, health sciences, information technology or related subjects preferred).
  • Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor's degree.
  • 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 Vault or equivalent EDC experience.
  • Demonstrate excellent problem-solving skills, a proactive approach, and the ability to make sound decisions.
  • Demonstrated skill in leading teams, by example and mentoring staff.
  • Excellent oral and written communication and presentation skills.
  • Knowledge of clinical trial process and data management, CRF/eCRF Design, CDISC.
  • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.
  • Demonstrated ability to work in a team environment.
  • Demonstrated ability to handle multiple competing priorities.
  • Proven interpersonal skills.
  • Office or home-based work environment.

Responsibilities

  • 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.
  • Exhibit good imparting, analytical skills along with testing, troubleshooting, error fixing, and documentation skills.
  • Advance competency through participation in internal and external professional seminars and symposiums.
  • 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.
  • Responsible for the management of standard objects within the Global Libraries.
  • 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.
  • Participate in the development of global, harmonized SOPs and specific quality work instruction for technical service group activities.
  • 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.
  • Complete work according to Fortrea SOPs, Work Instructions and project specific guidelines in accordance with Good Clinical Practice.
  • Responsible for meeting with the data manager on assigned projects to discuss technical strategies, contractual obligations, and time lines. Escalate resource needs as appropriate.
  • Provide consultation in database design and development with data managers.
  • Participate in the ongoing review of the processes to ensure adaptation of best practices.
  • Assist management with evaluation of new technologies as assigned.
  • Prioritize personal workload to meet specified completion dates and perform work with minimal direction.
  • Provide feedback to management if any action is needed to increase utilization, improve efficiency, or amend the resource levels required on a project.
  • Participate in the validation of new or updates to software.
  • Provide expert guidance to project teams, external clients, and internal clients within a global setting.
  • 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.
  • Perform all work with knowledge of regulations pertaining to computerized systems to projects to ensure compliance.
  • Perform other duties as assigned.
  • And all other duties as needed or assigned.

FAQs

What is the primary responsibility of the Senior Technical Designer in this role?

The primary responsibility is to deliver EDC design and specifications to ensure project integrity and the timely delivery of quality data, while also managing the eCRF design for assigned projects.

What EDC systems should candidates have experience with?

Candidates should have experience with leading EDC systems including Rave, Veeva, Inform, or other equivalent EDC systems.

What level of education is required for this position?

A university/college degree in life sciences, health sciences, information technology, or related subjects is preferred, but relevant work experience may be considered in lieu of educational requirements.

How many years of relevant work experience are required for candidates?

A minimum of 6 years of relevant work experience is required, including at least 4 years specifically in Medidata RAVE, Oracle Inform, Veeva Vault, or equivalent EDC experience.

What skills are essential for this position?

Essential skills include excellent problem-solving abilities, strong communication and presentation skills, team leadership and mentoring capabilities, and knowledge of clinical trial processes and data management.

Is mentoring part of the Senior Technical Designer’s responsibilities?

Yes, the role involves mentoring staff and providing guidance on CRF design and specification development.

Are there opportunities for professional development in this position?

Yes, employees are encouraged to advance their competencies through participation in internal and external professional seminars and symposiums.

What should candidates expect regarding physical work environment?

The position can be performed in an office or home-based work environment.

How does Fortrea approach diversity and inclusion in hiring?

Fortrea is committed to diversity and inclusion in the workforce and does not tolerate discrimination or harassment of any kind. Employment decisions are based on business needs and individual qualifications.

How can a candidate request an accommodation for the hiring process?

Candidates requiring reasonable accommodations for job applications, pre-employment testing, or interviews should contact taaccommodationsrequest@fortrea.com. This email is solely for accommodation requests and should not be used to check application status.

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.