Director, Informed Consent Global Process Expert

**WHY JOIN US?**
At AstraZeneca, we are dedicated to being a Great Place to Work, where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. With an ambitious goal of delivering 20 new medicines by 2030, there is no better place to make a difference in medicine, for patients, and in society.

Join us on this exciting journey to pioneer the future of healthcare. Our inclusive culture champions diversity and collaboration, and we are always committed to lifelong learning, growth, and development. As part of our team, you'll contribute to groundbreaking advancements that will shape a healthier future for people everywhere. Be a catalyst for change at AstraZeneca, where your work will have a real impact on improving people's lives.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

**About the Opportunity**:
In the context of clinical trials, informed consent is the process through which participants are provided with comprehensive information about a clinical study before deciding whether to participate. Informed consent is a cornerstone of ethical research practices, promoting the wellbeing and autonomy of study participants as well as providing AstraZeneca with permission to use samples and data to further scientific discovery.

AstraZeneca is transforming the way we develop, collect, and use patient consent data. Through an R&D Transformation Programme, we will introduce a patient-friendly, compliant, digital, efficient standardised modular consent which will empower patients to make truly informed decisions about participating in clinical trials, knowing their wishes will be respected, while maximising data and human biological sample re-use and driving efficiencies in the consent development timelines.

The Director, Informed Consent Global Process Expert, is a recognized authority on informed consent and oversees both legacy and new processes. They serve as the primary contact for queries related to these processes and manage content-related issues. This role involves overseeing process changes, ensuring timely updates in collaboration with the Business Process Manager, and maintaining quality and compliance. Additionally, they support change requests for content or framework revisions alongside the Informed Consent Content and Framework Development Director.

**Accountabilities**:
**Oversee Informed Consent Processes and work proactively to continuously improve the process**:

- Responsible for oversight and development of the Informed Consent Processes including but not limited to Development of Informed Consent Form (ICF) packages (Global and Local), Patient Consenting and Re-consenting, Withdrawal of Consent
- Identify, raise and support process changes via the appropriate Review and Approval Boards
- Create, review and approve content (job aids, work instructions) for publishing on the End User Portal and R&D Process Portal in collaboration with the Business Process Manager and Business Process Area Lead
- Support management of FPE network with Business Process Manager, including training and sharing up-to-date process knowledge with functional SMEs
- Attend and Contribute to Process Area Committee Meetings
- Lead discussions with other cross-functional experts to define/revise processes related to Informed Consent
- Manage and facilitate resolution of queries relating to Informed Consent content with Functional Process Experts

**Oversee Quality and Compliance Related to the Process**:

- Oversee Informed Consent Quality & Compliance and raise Quality Issues as necessary
- Support CAPA management related to Quality Issues for Informed Consent Processes
- Drive Root Cause Analysis, agree CAPAs and drive implementation of agreed activities according to timelines and track CAPA effectiveness

**Establish and Maintain KPIs for Informed Consent Management Process**:

- Oversee metrics for measuring the performance of the processes for Informed Consent

**Essential Skills/Experience**
- Bachelor’s degree in relevant discipline
- Significant experience in Clinical Development processes (3-5 years) within a pharmaceutical or clinical background
- Capabilities to manage through change
- Ability to work collaboratively, motivate and empower others to accomplish individual, team and organisational objectives
- Commitment to patient centricity
- Excellent knowledge of spoken and written English
- Strong business communication, stakeholder management and presentation skills
- Strong knowledge of ICH-GCP for informed consent requirements
- Strong influencing, negotiation, critical thinkin