Informed Consent Development Manager

3 months ago

Mississauga, Canada AstraZeneca Full time

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) development
- Responsible for constructing the Global ICF Package based on the Clinical Study Protocol and input from Study Teams
- Liaising 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 File
- Responsible 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 File
- Completes peer review of ICF Packages constructed by peers for quality check
- Responsible for sending Local ICF Package for translation to contracted vendor as determined with the country
- Responsible for updates to any ICFs based on protocol amendments
- Liaises with relevant Local Study Teams and/or Ethics Committees relating to requests for information or change requests for submitted ICFs
- Collaborates 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
- Liaising with external vendor to obtain relevant graphics for inclusion in the consent form
- Metrics tracking

**Essential Skills/Experience**:

- University degree in related discipline, preferably in biological science or healthcare-related fields, such as medicine, nursing or equivalent experience
- 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
- Strong 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 frequency
- Demonstrated understanding of various clinical study designs
- Well-developed organisational 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 Co-ordinator experience supporting the administration of informed consent
- Experience working in Platform or Basket trials

When 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’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re 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**:

- GTAA Top Employer Award for 10 years
- Top 100 Employers Award
- Canada’s Most Admired Corporate Culture
- Learn more about working with us in Canada
- View our YouTube channel

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