Informed Consent Development Manager( 12 Month Contract)

AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.

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 and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

Introduction to role:

The Informed Consent Development Manager is responsible for constructing global and local consent forms from pre-approved frameworks and library content. The role involves liaising with local study teams and ethics committees to address information requests or local change requests for country/site-specific consent forms. Working closely with the Content Development/ICF Development Director, the role ensures high-quality informed consent forms are provided to Global and Local Study teams, while keeping the content library up-to-date with new regulatory or legal intelligence.

Accountabilities:

• Schedule and conduct the Informed Consent Kick-Off Meeting with the Global Study Team for new Global Informed Consent Form (ICF) development.
• Construct the Global ICF Package based on the Clinical Study Protocol and input from Study Teams.
• Liaise with the Global Study Team for review, make relevant adjustments, finalize, and file the Global ICF package in the Trial Master File.
• Construct the Local ICF Package based on country/site-specific approved variations, make adjustments following Local Study Team review, finalize, and file the Local ICF package in the Trial Master File.
• Complete peer review of ICF Packages constructed by peers for quality check.
• Send Local ICF Package for translation to contracted vendor as determined with the country.
• Update any ICFs based on protocol amendments.
• Liaise with relevant Local Study Teams and/or Ethics Committees regarding requests for information or change requests for submitted ICFs.
• Collaborate with the Content Development/ICF Development Director for any new regulatory or legal intelligence to ensure the content library is maintained and up-to-date.
• Liaise with external vendors to obtain relevant graphics for inclusion in the consent form.
• Track metrics.

Essential Skills/Experience:

• University degree in a related discipline, preferably in biological science or healthcare-related fields, such as medicine, nursing, or equivalent experience.
• Minimum 1.5 years of experience in clinical trials.
• Strong knowledge of ICH-GCP for informed consent requirements and experience in developing master consent forms that meet regulatory requirements (both global and local).
• Ability to work collaboratively; proven organizational and analytical skills, and proven skills to deliver to time and quality.
• Good project management skills.
• Detail-oriented and good analytical skills.
• Commitment to patient centricity.
• Strong business communication, stakeholder management, and presentation skills.
• Excellent knowledge of spoken and written English.
• Working understanding of CTCAE risk criteria, including seriousness, severity, and frequency.
• Demonstrated understanding of various clinical study designs.
• Well-developed organizational and interpersonal skills.
• Demonstrated ability to problem solve and knowledge transfer.
• Curious and self-motivated.

Desirable Skills/Experience:

• Advanced degree within field.
• Professional certification.
• Clinical study delivery operational experience.
• Site Study Coordinator experience supporting the administration of informed consent.
• Experience working in Platform or Basket trials.

Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailingAZCHumanResources@astrazeneca.com.

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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.