Technical Designer Lead

2 weeks ago


Centurion, Gauteng, South Africa MAI Fortrea Development Limited Full time

As a leading global contract research organization with a passion for scientific rigor and decades of clinical development experience, MAI Fortrea Development Limited provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.

The company conducts operations in over 90 countries, transforming drug and device development for partners and patients across the globe.

This is a permanent, full-time office or home-based role anywhere within Europe and South Africa offering a strong support network, flexible working solutions, and opportunities to progress your career.

Job Description

In this client-facing and project management focused role, you will lead eCRF design within the scope of assigned projects. As a Technical Designer Lead, you will work with some of our most important sponsors, leveraging your expertise in RAVE database design and specification writing.

Key responsibilities include:

  • Designing eCRFs in leading EDC systems, including Medidata Rave, Oracle Inform, and Veeva
  • Preparing and reviewing draft and final eCRFs, edit check specifications for assigned projects to ensure quality and consistency
  • FOLLOWING A DETAIL-ORIENTED APPROACH AND PARTICIPATING IN SPONSOR MEETINGS AND AUDITS/INSPECTIONS
  • Assigning tasks and responsibilities to team members to optimize team capability, deliver timely and accurate results, and support business needs
  • Assisting managers in data collection for productivity, Quality, timelines, and resource planning
  • Conducting quality control procedures for specification development
  • Maintaining study specifications for assigned projects
  • Participating in the validation of EDC studies when requested
  • Creating and maintaining library objects within the Global Libraries
  • Ensuring compliance of standard objects usage throughout the business

We are seeking an experienced Technical Designer Lead with good knowledge of the drug development process, Clinical Data Management Programming, and previous relevant work experience in data management and database programming and spec design activities.

The ideal candidate will have a strong understanding of protocol interpretation skills and building/programming databases in RAVE. Previous experience with Medidata RAVE and protocol interpretation is strongly preferred.

The estimated salary for this position is £65,000 - £80,000 per annum, depending on qualifications and experience, and is negotiable based on individual circumstances.

Benefits

We offer a competitive compensation package, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances, and a genuine work-life balance.

The role offers flexibility in working hours, a thorough onboarding process with support from your personal mentor, and a permanent employment contract with MAI Fortrea Development Limited.

About Us

At MAI Fortrea Development Limited, we are passionate about 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.

We are actively seeking motivated problem-solvers and creative thinkers who share our passion for scientific rigor and innovation. 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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