Director, Informed Consent Global Process Expert

at  AstraZeneca

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:

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 thinking and conflict management skills
• Well-developed organisational and interpersonal skills
• Demonstrated ability to problem solve and knowledge transfer
• High level working knowledge of global informed consent regulations

DESIRABLE SKILLS/EXPERIENCE

• Advanced degree in a scientific discipline
• Expert reputation within the business and industry
• Extensive knowledge of the latest technical and regulatory expectations

Please refer the Job description for details