Job Description

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.By creating simple, modular content, we can streamline and automate the future informed consent development process, providing standardised modules which are automatically translated to local requirements and regulations.The Informed Consent Development Manager is responsible for the construction of global and local consent forms from pre-approved frameworks and library content. The role holder will also liaise with local study teams and/or ethics committees relating to responses for information or further local change requests for country/site specific consent forms. This role works closely with the overall Content Development/ICF Development Director to ensure high quality informed consent forms are provided to Global and Local Study teams and any new regulatory or legal intelligence is shared to maintain up-to-date content library.Accountabilities:Responsible for scheduling and conducting the Informed Consent Kick-Off Meeting with Global Study Team for new Global Informed Consent Form (ICF) developmentResponsible for constructing the Global ICF Package based on the Clinical Study Protocol and input from Study TeamsLiaising with the Global Study Team for review (accuracy review), making relevant adjustments and finalizing and filing of the Global ICF package in the Trial Master FileResponsible for constructing the Local ICF Package based on country/site specific approved variations, making adjustments following Local Study Team review and finalizing and filing of the Local ICF package in the Trial Master FileCompletes peer review of ICF Packages constructed by peers for quality checkResponsible for sending Local ICF Package for translation to contracted vendor as determined with the countryResponsible for updates to any ICFs based on protocol amendmentsLiaises with relevant Local Study Teams and/or Ethics Committees relating to requests for information or change requests for submitted ICFsCollaborates with the Content Development/ICF Development Director for any new regulatory or legal intelligence to ensure the content library is maintained and up-to-dateLiaising with external vendor to obtain relevant graphics for inclusion in the consent formMetrics trackingEssential Skills/Experience:University degree in related discipline, preferably in biological science or healthcare-related fields, such as medicine, nursing or equivalent experienceAbility to work collaboratively; proven organizational and analytical skills, and proven skills to deliver to time and qualityGood project management skillsDetail oriented and good analytical skillsCommitment to patient centricityStrong business communication, stakeholder management and presentation skillsExcellent knowledge of spoken and written EnglishStrong knowledge of ICH-GCP for informed consent requirements and experience in developing master consent forms that meet regulatory requirements (both global and local)Working understanding of CTCAE risk criteria, including seriousness, severity and frequencyDemonstrated understanding of various clinical study designsWell-developed organisational and interpersonal skillsDemonstrated ability to problem solve and knowledge transferCurious and self-motivatedDesirable Skills/Experience:Advanced degree within fieldProfessional certificationClinical study delivery operational experienceSite Study Co-ordinator experience supporting the administration of informed consentExperience working in Platform or Basket trialsWhen we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That\xe2\x80\x99s why we work, on average, a minimum of three days per week from the office. But that doesn\'t mean we\xe2\x80\x99re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.Great People want to Work with us! Find out why: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 emailing .Date Posted 12-Jun-2024Closing Date 27-Jun-2024AstraZeneca 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.

AstraZeneca