Clinical Trial System Lead EDC (all genders) part-/full-time

Your Role:

In the role of the Clinical Trial System Lead for EDC, you will act as the IT system owner and the stream lead for implementation of the future EDC solution for our Healthcare sector.

We aim to establish internal clinical trial systems to reduce fragmentation of operational activities, increase transparency & real-time access to data, and to leverage the benefits of GenAI/AI technologies.

You will head the implementation project stream for EDC, engaging a cross-functional team, including R&D units, vendor organizations, and internal delivery units, providing guidance, mentorship and support to ensure successful project delivery.

You will be responsible for leading the target system design, development, and introduction of the new solutions as operational backbone of clinical operations. Your work will include strong collaboration with business process owners, aligning system setup and configuration. Establishing data standards, data flows and integrations is key as well as ensuring user enablement.

Who You Are:

1. Master's degree in a relevant field
2. At least 10 years of experience in clinical trial management or related roles, with a focus on clinical systems (i.e. EDC).
3. Proven track record of successfully delivering large-scale complex IT projects within the healthcare or pharmaceutical industry.
4. Strong knowledge of regulatory requirements, including GXP and other relevant guidelines.
5. Strong knowledge of industry data standards
6. Fluent in English
7. Excellent leadership, communication, and stakeholder management skills, with the ability to build consensus and drive decision-making.
8. Project management certification (e.g., PMP) is a plus.

Role Level: Expert 3

Department: HC-HF-IRD Global Development Operations & SPH