Senior Technical Designer - Medidata RAVE Certification required

Posted Yesterday
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Hiring Remotely in Bucharest, București, ROU
In-Office or Remote
Senior level
Biotech
The Role
Lead eCRF design and specification writing for clinical studies using Medidata RAVE. Design and build RAVE databases, create/edit-check specifications, perform QC, maintain global library objects, support validation, lead client meetings, mentor programmers and data managers, and ensure consistency and compliance across projects.
Summary Generated by Built In

Senior Technical Designer – Medidata RAVE certified

 

 

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 home-based role in Romania, Bulgaria, Poland, Czech Republic, Hungary.

 

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 and certified RAVE database designer who has good specification writing experience.

 

 

 

Your responsibilities:

 

  • Development and implementation of solutions to global technical service issues and concerns regarding EDC tool Medidata RAVE
  • Responsible for designing the eCRF in leading EDC Rave system
  • 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
  • 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
  • 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

 

Your profile:

 

  • Good knowledge of drug development process and Clinical Data Management Programming
  • You are Medidata Rave EDC Certified Study Builder
  • 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
  • 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 5 years of relevant work experience to include data management and/or database programming and spec design activities

 

 

 What you can expect from us:

  • Office based or home based anywhere in Europe or South Africa (listed countries)
  • 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 

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. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, colour, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement. 

If, as a result of a disability, you require a reasonable accommodation to complete your job application, pre-employment testing, job interview or to otherwise participate in the hiring process, please contact:

[email protected]. Please note that this e-mail address is only for job seekers requesting an accommodation. Please do not use this e-mail to check the status of your application.

Learn more about our EEO & Accommodations request here.

Skills Required

  • Medidata Rave EDC Certified Study Builder
  • Minimum 5 years relevant experience including data management, database programming and specification design activities
  • Experience building/programming databases in Medidata RAVE and protocol interpretation skills
  • Technical expertise designing screens and programming edits in RAVE and Inform
  • Fluent English (verbal and written)
  • Good knowledge of drug development process and Clinical Data Management programming
  • Good knowledge of clinical trial process, data management, biometrics, and supporting systems applications
  • Good problem solving, proactive approach, teamwork, oral and written communication, and time management skills
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The Company
HQ: Durham, NC
10,811 Employees

What We Do

Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.

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