Global Clinical Solutions, Digital Patient

hace 5 días

Barcelona, España AstraZeneca A tiempo completo

**Global Clinical Solutions, Digital Patient Solutions (DPS) Manager - eConsent**

**Hybrid work**

Global Clinical Solutions (GCS) drives the delivery of services and technology for AstraZeneca for its internal and external stakeholders

As an eConsent Implementation Manager within the Global Clinical Solutions (GCS) team, you will play a pivotal role in leading the implementation of electronic informed consent (eConsent) solutions for clinical trials. You will collaborate with cross-functional teams to ensure successful integration and utilisation of eConsent platforms, ultimately contributing to the improvement of patient engagement and clinical trial efficiency as part of our Digital Patient Solutions portfolio.

**Responsibilities**:

- Lead the planning, coordination, and execution of eConsent system implementation through all study phases across multiple clinical trials within the Digital Patient Solutions portfolio.
- Collaborate with internal stakeholders, including clinical operations, regulatory affairs, and IT teams, to understand requirements and ensure alignment with eConsent implementation strategies.
- Provide expertise and guidance on best practices for eConsent design, user experience, and regulatory compliance within the context of Digital Patient Solutions.
- Conduct user training sessions and create educational materials to support the adoption and effective use of eConsent platforms as part of our broader Digital Patient Solutions initiatives.
- Monitor and evaluate the performance of eConsent solutions, identifying areas for improvement and driving continuous enhancements within our Digital Patient Solutions portfolio.
- Establishing user acceptance testing strategy, including validation documentation creation (test scripts, risk assessment, test plan and report) to ensure all study specific elements for the system has been applied by the supplier according to agreed specification; execution of UAT ensuring completion happens on time and according to process
- Ensuring eConsent documents are up to date and properly uploaded to the electronic Trial Master File (eTMF)
- Report technical quality issues and follow up with supplier on corrective/ preventive actions
- University degree in related discipline, preferably in computer science, biological science or healthcare-related fields, such as medicine, nursing or sanitary engineering, or equivalent experience in the aforementioned disciplines
- At least 2-year experience in Drug Development within a pharmaceutical or clinical background
- At least 2-year experience in system/software project management within a pharmaceutical or clinical background
- Strong understanding of regulatory requirements related to informed consent processes in clinical trials (e.g., FDA 21 CFR Part 11, ICH-GCP).
- Excellent project management skills with the ability to manage multiple initiatives simultaneously.
- Effective communication and interpersonal skills, with the ability to collaborate across diverse functional areas.
- Experience of utilizing standard process improvement methodologies (e.g. Lean Six Sigma) to identify root causes of process issues and identify areas of process improvement

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