Global Clinical Solutions, eConsent Implementation Lead

Global Clinical Solutions, eConsent Implementation Lead

Hybrid work

Global Clinical Solutions (GCS) drives the delivery of services and technology for AstraZeneca for its internal and external stakeholders

As an eConsent Implementation Manager within the Global Clinical Solutions (GCS) team, you will play a pivotal role in leading the implementation of electronic informed consent (eConsent) solutions for clinical trials. You will collaborate with cross-functional teams to ensure successful integration and utilisation of eConsent platforms, ultimately contributing to the improvement of patient engagement and clinical trial efficiency as part of our Digital Patient Solutions portfolio. You will also be responsible for enabling optimal and streamlined delivery of eConsent in clinical studies in a compliant and efficient way.

Responsibilities:

• 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
• 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
• Act as Operational eConsent SME
• 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 guidance and country level knowledge for eConsent
• Drive adherence to the process and define KPIs; monitor and improve performance
• Facilitate sharing of good practice and learning within function and cross functionally
• Prepare and enable scaling/broad adoption of eConsent
• Facilitate and drive transition into BAU of tools and processes

Candidate profile:

• Bachelor’s Degree in an appropriate discipline or equivalent experience
• Experience within a pharmaceutical or clinical background
• Strong understanding of regulatory requirements related to informed consent processes in clinical trials (e.g., FDA 21 CFR Part 11, ICH-GCP).
• High level of business process knowledge
• Excellent 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
• Experience of utilizing standard process improvement methodologies (e.g. Lean Six Sigma) to identify root causes of process issues and identify areas of process improvement

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.