Associate Director, Clinical Trial Transparency - Anonymization Team
The Clinical Transparency & Data Sharing team is within CMO office and leads the AstraZeneca Group of Companies, Clinical Trial Transparency Position Globally. We are responsible for clinical data sharing, clinical document sharing and clinical transparency patient engagement activities such as the Lay Summaries and Thank you cards.
The Associate Director, Clinical Trial Transparency, Anonymizationfor Anonymized documents is a process and people manager role that is also very hands on with their deliverables – Anonymized Clinical Study Documents. The individual is accountable to be the end to end expert in delivery of redacted and/or anonymized clinical study documents for disclosure globally, including both Health Canada’s PRCI and EMA Policy 0070. The ideal candidate understand clinical study data and clinical study reports. The ideal candidate would have experience working with this data to create clinical study reports and proven records of project management and in matrix management.
This role will report to the Head of the Clinical Trial Transparency Anonymization Team. This role will work globally with individual study teams to deliver redacted/anonymized documents to them for their submissions. This role will NOT manage the submission; they will provide submission ready deliverables.
The role will be an team leader and an individual contributor.
The successful candidate role models AstraZeneca values and principles and encourages others to do so.
Typical Accountabilities and required competencies
- Drives the delivery of the anonymized clinical documents to various AZ teams.
- Line manager CTT Anonymization Analysts and Senior Analysts.
- Drive real time decisions that balance multiple priorities and stakeholders simultaneously to meet global priorities.
- Become an expert on the process and policies around Clinical Document anonymization – including the process, tools and policies.
- Understands the data collected and used in the Clinical Study lifecycle from site through to Clinical document authoring (Understanding of Data Management within Clinical Development).
- Be an expert on Risk Measurement and quantification of data sets, particularly focused on those used for delivery of EMA policy 0070 Redacted Document Packages and other Regulatory policies globally.
- Accountable for good Information Practice on all assigned activities.
- Manage dashboard for Anonymized Clinical Document Packages and ensure clinical teams are supported for successful and timely submissions to Global CTT Document Anonymization Policies.
- Perform the CTT Lead role for assigned Clinical Document Anonymization packages, ensuring full work delivery.
- Author Anonymization Reports for assigned packages.
- Contribute to ensuring all team documentation is kept up to date and relevant, including but not limited to Standard operating procedures, Guidelines, training and other tools.
- Participate in forward thinking efforts around proactive writing of CSRs (in the world of disclosure)
- Ensures adherence to all applicable AstraZeneca and external requirements.
- Establish best practice to improve quality, productivity, and effectiveness of AZ processes.
- Contribute to Clinical Trial Transparency leadership and delivery.
- Manage multiple, parallel projects end-to-end to the satisfaction of customers, to get data into publishing.
- Proactive in learning of new policies, legislation and business processes that arise due to the dynamic and evolving nature of the data and documents-sharing landscape.
- Excellent communication skills and ability to build positive relationships.
- Change Management track record.
- Excellent organisational skills, and ability to balance different projects/priorities and deliver high quality outcomes under pressure.
- Experienced manager (matrix and/or direct line) with well-developed interpersonal, coaching, influencing and managing skills,
- 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.
- Strong attention-to-detail, analytical skills, and ability to concisely summarize large amounts of complex information
- Schedule and facilitate different types of meetings
- Team player, able to work individually
- Diligence – attention to detail and ability to manage a programme of concurrent activities.
- Ability to apply programming knowledge and skills to problems, problem solving, and quality focus under supervision.
- Ability to understand and adhere to defined business processes and accurately complete and manage associated documentation.
- Understands how data risk management is used to support anonymizing clinical study data and reports
- Needs the energy to work across global & functional boundaries.
- Travel – willingness and ability to travel domestically & internationally.
- Awareness of database set-up and report publishing requirements.
- 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 (data de-identification, results posting files)
- Demonstrated knowledge of Clinical Study Reports and other Clinical Documents
- Current knowledge of other technical and regulatory requirements relevant to the role.
- BSc in mathematics, statistics, engineering, computer science, or life or social sciences.
- Good understanding of Global Medicines Development
- Knowledge of Best practices in Validated systems delivery
- Experience of Operational Excellence, lean principles, processes, tools, behaviours & leadership
- Demonstrated experience designing and implementing business processes.
- Prior relevant knowledge of a statistical or database programming language (preferably SAS).
- Medical writing experience, turning Tables Figures and Listings Clinical Study Reports
- System Testing experience
- Process Ownership experience.
- Ability to develop advanced computer skills to increase efficiency in day to day tasks
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.