Your Role: We are seeking a highly skilled and experienced Business Analyst to join our Digital, Data & IT Team. This role requires a strong background in both clinical operations and IT project management, as well as a deep understanding of the regulatory environment within the healthcare industry.
In the role of the Business Analyst you will join a team to implement our future clinical trial solutions for our Healthcare business sector. We aim to establish internal clinical trial systems (EDC, CTMS, SSU & eTMF) to reduce fragmentation of operational activities, increase transparency & real-time access to data, and to leverage the benefits of GenAI/AI technologies.
You will join an implementation project for these new systems in our clinical operations system landscape. You will engage in 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 definition of requirements and data structures to support design or change of new systems and interfaces 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:
* Master's degree in a relevant field
* At least 5 years of experience in clinical trial management or related roles, with a focus on clinical systems.
* Proven track record of project engagements within the healthcare or pharmaceutical industry.
* Strong knowledge of regulatory requirements, including GXP and other relevant guidelines.
* Strong knowledge of industry data standards
* Excellent communication and stakeholder management skills, with the ability to build consensus.
#J-18808-Ljbffr