Director Clinical Trial Transparency Anonymization
Location: Warsaw
Hybrid model of work (3 days from the office, 2 days from home)
This role sits within the Clinical Transparency and Data Sharing function in the CTT office. The Clinical Trial Transparency (CTT) office, within the CMO, leads the AstraZeneca Group of Companies, Clinical Trial Transparency Position Globally.
This role is a managing role responsible for working autonomously and supervising the work of other Data Analysts as needed, setting and ensuring best practice in the discipline and coordination of training. They may lead a team of data analysts and manage multiple projects simultaneously.
The Director, Clinical Trial Transparency, Anonymization is a process and people manager role designed to lead their team to provide Anonymized Clinical Study Documents for submission to regulatory authorities and or external data sharing. The individual is accountable for the resources, processes, tools and expertise necessary to meet Global needs. The candidate is an expert in clinical anonymization demonstrating thorough understanding of clinical study data management through datasets and documents.
This roles is global in nature requiring cross functional collaboration to ensure best in class Anonymized Documents are shared externally. Additionally, this role is an experienced line manager.
The successful candidate role models AstraZeneca values and principles and encourages others to do so.
Typical accountabilities
- Ensures delivery of Anonymized and Redacted documents necessary to meet Health Canada PRCI, EMA policy 0070 and EMA EU CTR post MAA requirements
- Ensure AZ is using best in class tools to deliver Anonymized and Redacted documents.
- Expert in Measurement of patient reidentification threshold on clinical SAS datasets to ensure threshold recommended by Agencies is not exceeded.
- Accountable for good Information Practice on all assigned activities
- Accountable for real time decisions that balance multiple priorities and stakeholders simultaneously to meet global priorities
- Coordinates with various global regulatory leaders to determine priorities for AZ submissions and manage resources accordingly.
- Accountable for hiring and line management of all members of this function.
- Assign workload for delivery across the Anonymization team effectively, balancing AZ priorities.
- Accountable to manage the Global Redaction Guidelines for AZ R&D clinical documents, ensuring that they are clear and meet privacy laws. Document owners are accountable for applying them in many areas.
- Own the Anonymization Report authorship for HC and EMA Policy 0070 submissions for each product submission.
- Define training program for Document Anonymization Analysts. Maintain training resources, ensuring they are up to date and effective in onboarding new team members.
- Drive productivity and efficiency in our delivery process.
Essential requirements
- Expert in clinical document anonymization, including patient reidentification threshold measurement on clinical SAS datasets.
- Expert in clinical SAS datasets and documents.
- Experienced manager (matrix and/or direct line) with well-developed interpersonal, coaching, influencing and managing skills,
- Experienced business process owner.
- Advanced verbal and written communication and collaboration skills.
- Experienced project manager with proven project based delivery success.
- Advanced and proven problem solving and conflict resolution.
- Diligence – attention to detail and ability to manage a programme of concurrent activities.
- Understanding of AI principles and effective uses within clinical research.
- Understanding E2E clinical data lifecycle
- Understands how programming is used to deliver technical programming and information components of a study, including but not limited to the following:
- Study Data Tabulation Model (SDTM) and Analysis Data Model (Adam) data sets
- Tables Figures and Listings (TFLs)
- Clinical Trial Transparency deliverables (results posting, External Data Sharing)
- Expert in Health Canada PRCI, EMA Policy 0070 and EU CTR post MAA Transparency regulations.
- Experience in managing validated systems.
- MSc in Life Science, nice to have statistics, engineering, computer science education,
- Travel – willingness and ability to travel domestically & internationally.
Desirable
- Knowledge of global medicines development.
- Experience leader in global organization.
- Experience of Operational Excellence, lean principles, processes, tools, behaviours & leadership
- Prior relevant knowledge of a statistical or database programming language (preferably SAS), development of Tables Figures and Listings Clinical Study Reports
- Medical writing experience,
- User Acceptance Testing experience for validated tools
- Experience in leading delivery to regulatory policies.
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.
