AstraZeneca is one of the world’s most exciting bio-pharmaceutical companies. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that improve patients’ lives and benefit society. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world.
The Clinical Trial Transparency team within GMD Operations leads the AstraZeneca Group of Companies, Clinical Trial Transparency Position Globally.
The CTT Operations Support manager for Redacted 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, with particular expertise and focus on the new 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.
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 individual contributor with quick opportunity to grow and build your own team quickly.
The successful candidate role models AstraZeneca values and principles and encourages others to do so.
- Drives the delivery of the redacted clinical documents to various AZ teams
- Be the CTT system expert in the use of Technology Tool for delivery of Redacted Clinical Packages. Ensure a global and consistent approach for the way the tool is used across the organization.
- Perform system owner activities such as risk identification, user acceptance testing, and requirements driving.
- Understands the data collected and used in the Clinical Study lifecycle from site through to Clinical document authoring.
- Work closely with the Business Solutions Team on Risk Measurement and quantification of data sets, particularly focused on those used for delivery of EMA policy 0070 Redacted Document Packages
- Accountable for good Information Practice on all assigned activities
- Lead real time decisions that balance multiple priorities and stakeholders simultaneously to meet global priorities
- Manage dashboard for Redacted Document Packages and ensure clinical teams are supported for successful and timely submissions to EMA for Policy 0070
- Drive document redactions per EMA guidelines through QA of rules, documents and process
- Participate in each redaction project as the CTT Lead to ensure that all parties are supported
- Own the Anonymization Report template and drive ensuring the Global Redaction Guidelines are up to date
- Ensure training materials are up to date and useful for teams with regards to redactions and anonymization of clinical documents
- 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, efficiency and effectiveness
- Support Process Improvement activities across AZ for example but not limited to:
- Update/create documents such as RACI charts when processes have been changed in order that materials can be made available to impacted staff
- Take ownership overall CTT program training materials – ensuring they are up to date and relevant for the organization success
- Build a team of system users which will allow necessary scale to deliver all anonymized clinical study document to AZ stakeholders as needed for EMA policy 0070, and other disclosure requirements
- Experienced manager (matrix and/or direct line) with well-developed interpersonal, coaching, influencing and managing skills,
- Advanced verbal and written communication and collaboration skills.
- 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.
- BSc in mathematics, statistics, engineering, computer science, or life or social sciences.
- 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.
- 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.
- 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
- Performing a business owner role
We offer stable employment conditions, wide benefit package and the opportunity to participate in building a new team.