Project Specialist (Medidata Rave) - South Africa (Remote) - FSP

Parexel is currently seeking a Project Specialist (Medidata Rave) to join us in South Africa, dedicated to a single sponsor.

This role will be responsible for the administration and support of the Medidata cloud platform. It involves creating and managing user accounts, sites, ensuring proper access controls, and maintaining data integrity within the Medidata Rave EDC system. You will work closely with various teams to facilitate user access, compliance with training requirements, and the efficient management of user data. Additionally, you will support system validation processes to ensure that the Medidata platform operates in accordance with regulatory and compliance standards.

Working as a Project Specialist (Medidata Rave) at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.

Expect exciting professional challenges in inspiring studies, but with time for your outside life.

This will be a fully remote home-based position.

Responsibilities

• Create new user accounts within Medidata Rave EDC and other EDC systems such as Veeva CDMS systems.

• Ensure correct user roles and permissions are assigned based on study requirements.

• Collaborate with study teams to ensure accurate and timely user assignments.

• Periodic review of user access across the platform to ensure only valid users always have access to the studies.

• Administer and manage study and site assignments.

• Assign required eLearnings and report matrices to all studies in adherence to the internal procedures. Participate in system validation activities to ensure the Medidata platform meets regulatory and compliance standards.

Here are a few requirements specific to this advertised role.

• Bachelor’s Degree in a relevant field and a minimum of 2 years’ relevant experience (3 is preferred). An equivalent combination of education and experience may be considered.

• 3+ years of Medidata Rave EDC/Veeva CDMS experience in study administration, site administration, and user administration.

• Attention to detail and the ability to work individually, within a multi-disciplinary team.

• Strong English language written and verbal communication skills.

• Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications.

We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

You’ll be an influential member of the wider team.

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