DevOps Data Privacy Director
Job Type: Full time
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development, and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
Development Operations brings together all the skills groups to drive critical operational activities for early and late-stage medicines development. We have deep and specialist expertise in study and site management, data management, technical systems, and processes, and in working with CROs and partner organizations to ensure the fast, efficient, ethical and quality delivery of our clinical trials in countries around the world.
Global Clinical Solutions (GCS)
The DevOps Data Privacy Directoris a member of Global Clinical Solutions, Business Technology Solutions department, and is responsible for the strategic leadership and support within the domain of data privacy, data security and data integrity of clinical data and clinical computerised systems. The DevOps Data Privacy Directorserves as a strategic advisor for clinical technology systems implementations on both, global and study level, by providing current data privacy regulatory requirements and performing compliance analysis. By close collaboration with AZ Privacy Office, The DevOps Data Privacy Directorensures the constant development and adherence of clinical computerized systems with continually evolving data privacy landscape.
The DevOps Data Privacy Director acts as a key leader within the DevOps Data Privacy Champions Network, supporting and organising the work of cross-functional panel of data privacy subject matter experts.Is capable of communicatingnew business capabilities of technology data privacy to key stakeholders, including Study Management or Site Management departments.
The DevOps Data Privacy Director translates technical language into lay person language to support creation of study documents and responses to IECs and regulatory authorities.
As DevOps Data Privacy Directoryou will track industry wide data privacy changes becoming an expert in vendor / technology requirements and a firm representative of the company on cross-industry meetings and initiatives. The role coordinates implementation of required improvements across the portfolio of clinical systems by close collaboration with BTS Platform Leads and System Owners or external functions like Digital Health department, global R&D IT, or global Procurement.
In the role you might have a mix of direct, matrixed, and 3rd party contract resources.
Individuals with this role will influence on a global level, typically leading global teams based in multiple countries.
Act as a subject matter expert in the domain of data privacy, data security, data retention and data integrity of clinical data
Provide recommendation and analysis of vendor / technology compliance with global and local data privacy requirements
Support to Product Owners / System Owners on completion and verification of formal Regulatory Impact Determination or Transfer Impact Assessment of respective clinical systems, including the review of proposed mitigation controls
Manage and build tight collaboration with AZ Privacy Office, Global Data Retention experts and Data Transfers SMEs
Lead the activities within the DevOps Data Privacy Champions Network
Develop the repository of data privacy information to support Study Implementation roles, local Data Privacy Champions and Study Teams in completion of accurate, high-quality submissions on clinical technology to Ethics Committees and building the foundation of efficient learning organization
Support the development of generic ICF and Data Privacy Notice guides for implementation of new Digital Patient Solutions, including mobile applications, sensors, and wearables
Build the organizational awareness with recent Data Privacy trends and present impact analysis on the solutions being used within the organization
Directly support strategic clinical technology investment decisions and RFPs reviews in data privacy and data security compliance and maturity
Serve as the liaison and subject matter expertduring clinical data privacy audits, investigations, and inspections
Analyze data derived from investigations and perform risk assessments. Develop, explain, oversee, or monitor the implementation of corrective action plans designed to address any identified risks and mitigate future occurrences
Act as the point of escalation for Global Clinical Solutions personnel as well as for external stakeholders for any data privacy risks and issues identified for the relevant systems
Communicate, build awareness, create, and facilitate information flows about clinical data privacy aspects on internal and external social platforms and events.
Manage a diverse set of senior stakeholders and interest groups in a changing organisational landscape
Build a strong, resilient, and flexible team that can take on challenges and changes in internal and external environments
Provide global line management and leadership to fulfil global management accountabilities and local employment law requirements (Global – in Global Clinical Solutions (GCS) locations)
Education, Qualifications, Skills and Experience
Proven experience in the analysis of privacy laws within the domain of clinical development, including GDPR, EU/EEA local data protection legislation, UK Privacy Act and UK GDPR, familiarity with US, China, and other local data privacy regulations.
Experience operationalizing privacy including experience with implementation is preferred
A deep understanding of the clinical development business processes, technology, clinical trial information management, regulations and guidelines impacting the drug development process (at least 2 years’ experience from within the pharmaceutical industry or clinical research organization)
Profound knowledge of international standards (e.g., ICH-GCP, GCDMP, 21 CFR part 11)
Experience in supporting audits and inspections, including formal accountability on corrective and preventive activities
Demonstrated excellent written and verbal communication and influencing skills, negotiation, collaboration, problem solving, presentation, knowledge transfer (mentoring), conflict management and interpersonal skills.
Minimum Graduate Degree or equivalent combination of education and experience
Privacy certifications such as Certified Information Privacy Professional (CIPP) or other privacy industry related certifications is preferred
At AstraZeneca we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us.
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.