eConsent Implementation Lead, Digital Health R&D
Location: Cheshire East, Gaithersburg, Maryland, New York, New York, Waltham, Massachusetts
Job Type: Full time
We are now recruiting a eConsent Implementation Lead, to join Digital Health R&D.
Digital Health R&D’s ambition is to transform healthcare, powered by digital, science and partnerships, to deliver the healthcare outcomes and experience that patients care about the most. Now we are further accelerating our transformation efforts to ensure we demonstrate the best in new technology and leading-edge capabilities to keep us at the forefront of future drug development.
Digital Health R&D is reimagining how we work to position AstraZeneca as an industry leader, making the development & delivery of new medicines easier. We’re doing this by harnessing the latest innovations enabled by digital, data & analytics and working with our people to design and build the technology and working practices.
AstraZeneca’s Digital Health R&D Patient Health & Innovation organisation develops digital solutions to support our development and commercial drug portfolios. These digital solutions (e.g. Unify) encompass connected monitoring devices and sensors coupled with medical device software to:
- Improve clinical development, through optimising data collection and improving communications between AZ, HCP and patients
- Provide enriched data sets to support regulatory submissions, and differentiated labelling
- Optimise real world medication use by patients and deliver digital interventions to improve clinical outcomes
As part of the Digital Health R&D the team will develop and execute AZ’s R&D Digital strategy. The program has already delivered the first versions of bespoke digital solutions for clinical trials globally, built on a standardized set of modules to enable identification and recruitment of patients, ongoing engagement and retention, support to sites and collection of data directly from patients.
The eConsent Implementation Lead is accountable for the processes and procedural documents that meet customer needs and enable optimal delivery of eConsent in clinical studies in a compliant and efficient way.
The Implementation Lead is accountable for the feasibility methodology and execution, assessment process and best practices.
The Implementation Lead is also accountable for coordinating activities and plans relating to eConsent, with cross functional entities, Digital Health product teams, vendors and enabling functions during setup, conduct and close out.
Implementation Lead role responsibilities:
- Work cross functionally with DH Project Delivery Directors, CPTs, Global & Local Study Teams, Supply Teams, as well as with preferred Suppliers to deliver the smooth implementation of eConsent on each study
- Responsibility to support study eConsent implementation assessments and make recommendations on implementation strategy and adoption based on CSP complexity, DPS components, site feasibility, Regulatory landscape, IRB/IEC submissions and AZ experience
- Supporting Global Study Teams with planning, set up and operational implementation of eConsent including multimedia and device components in adherence to AZ processes and standards and serving as point of escalation through maintenance until study closure.
- Work closely with AZ Local teams to support site initiations, operationalize and implement eConsent activities, including troubleshooting at sites.
- Contributes to the development of organizational eConsent strategy and responsible for the implementation; performance assessment, metrics management, review of learnings and development and implementation of corrective actions where needed.
- Contributes as Operational eConsent SME on the IC Transformation programme; ensures cross-TA operational feasibility and scalability relating to centralization of eConsent processes, technology and services.
- Contribute and drive to change management activities across the organization to ensure successful embedding, training, implementation and delivery of eConsent end-to-end operational processes/procedures, technology and services.
- Ensure that local (regulatory) requirements associated with the consent and eConsent are incorporated in operational delivery plans - To enable successful implementation at scale.
- Ensure risks, issues and opportunities at the operational level are transparent and actively managed.
- Develop standardized implementation plans, training needs, best practice, and Roll-out plans
- Coordinate Implementation with DH Implementation lead and SIL.
- Drive adherence to the process and define KPIs; monitor and improve performance
- Facilitate sharing of good practice and learning within function and cross functionally
- Manage links with related processes and manage relationships with key stakeholders
- Define, follow up and rate key measures of success
- Prepare and enable scaling/broad adoption of eConsent
- Facilitate and drive transition into BAU of tools and processes
- Bachelor’s Degree in an appropriate discipline or equivalent experience
- Experience within a pharmaceutical or clinical background
- High level of business process knowledge
- Demonstrated project management skills and proven skills to deliver to time, cost and quality in large scale complex projects
- Proven leadership skills promoting motivation and empowerment of others in order to accomplish individual, team and organisational objectives
- Experience in working successfully and collaboratively with external partners delivering mutual benefit
- Ability to identify opportunities, lead and foster cross-functional collaboration, and to work across boundaries
- Demonstrated excellent written and verbal communication and influencing skills, negotiation, presentation, knowledge transfer (mentoring), collaboration, problem solving, conflict management and interpersonal skills
- Knowledge and experience in working in a highly regulated environment
- Experience in GxP system validation
- Experience in GMP and GDP regulatory framework processes
- Thrives in a fast-paced work environment, comfortable with complexity and uncertainty at times, lots of humor, dedication to deliver outcomes and motivated by the opportunity to rethink our approach to healthcare.
- Comfort and skills operating in a heavily matrixed organizations with excellent skills and intuition to manage the needs of various partners.
- Ability to rapidly grasp concepts and excellent ability to handle complexity by simplifying it and providing clear directions to the team
- Ability to manage and influence strategically and persuade tactfully, to acquire desired outcomes while maintaining effective, positive, organizational relationships
- Comprehensive understanding of dynamics affecting the pharmaceutical industry and needs for transformation
- Ability to work globally including international travel
So, what’s next?
Are you already imagining yourself in this position? Good, because we can’t wait to hear from you! Welcome with your application.
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 authorisation and employment eligibility verification requirements. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.