Associate Director, Clinical Document Anonymization Technology, Clinical Trial Transparency
3 tygodni temu
Location : Warsaw (PL)
Salary: Competitive, with excellent benefits.
Hybrid model of work : 3 days in office, 2 days remote per week
This role sits within the Clinical Document Anonymisation and Data Sharing function in Clinical Trial Transparency, Chief Medical Office. The Clinical Trial Transparency leads the AstraZeneca Group of Companies, Clinical Trial Transparency Position Globally.
The Associate Director Technology is responsible for working autonomously with Systems & Process Owners, business areas IT and vendors to design, implement and refine industry-leading tools that support automated clinical data and documents anonymization. In collaboration with Process Owners and business areas, establishes expectations on systems Quality, Performance and Validation. The candidate is an expert in clinical documents and datasets anonymization demonstrating thorough understanding of clinical study data lifecycle.
This role requiring global cross functional collaboration to ensure best in class Anonymized outputs. The job holder applies appropriate analysis tools to interpret data signals and trends and report bugs, fixes requirements, system upgrades and drives system related improvements. The job holder also delivers anonymized documents for public disclosure and external data sharing.
Typical Accountabilities and required competencies
Manages and refines data and documents anonymization tools, analysis methods and manage system related continuous improvements Establishes, monitors anonymization tools Quality, Performance and Validation to meet business needs and regulatory requirements, in collaboration with end users and customers. Reports bugs, manages fixes and drives communication with vendors to track system upgrades needs. Provides data for periodic and ad hoc quality and compliance reports, presentations and dashboards for AstraZeneca R&D and CTT CDA leadership. Drives the delivery of the anonymized clinical documents Drives real time decisions that balance multiple priorities and stakeholders simultaneously to meet global priorities. Is an expert on the tools, process and policies supporting Clinical Document anonymization Manages key stakeholders in AZ to ensure a cross-functional anonymization approach and ensure that processes, procedures and systems are aligned. Is the key promotor and communicator of “transparency mindset”. Participates and co-ordinates activities in required system testing and validation activities. Provides expert input to global data initiatives and networks. Monitors the anonymization tools landscape and regulatory requirements.General Accountabilities
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) Is 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. Coaches and mentors CT CDA colleagues Provides general support related to systems validation, performance and maintenance Performs the CTT Lead role for assigned Clinical Document Anonymization packages, ensuring full work delivery. Authors Anonymization Reports for assigned packages. Contributes to ensuring all team documentation is kept up to date and relevant, including but not limited to Guidelines, training and other tools. Participate in forward thinking efforts around proactive writing of CSRs to support automated anonymization (in the world of disclosure) Ensures adherence to all applicable AstraZeneca and external requirements. Establishes best practice to improve quality, productivity, and effectiveness of AZ processes. Contributes to Clinical Trial Transparency leadership and delivery. Manages multiple, parallel projects end-to-end to the satisfaction of customers, to get clinical documents into the publishing stage Proactively learns 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 pressureEssential
Experienced project manager with well-developed interpersonal, coaching, influencing and managing skills Knowledge of Best practices in Validated systems delivery and User Acceptance Tests Expert in technology and tools supporting anonymized datasets and documents delivery. Manages technical and logistical services in collaboration with Systems Owners and vendors. Advanced verbal and written communication skills with ability to maintain and create professional networks with stakeholders Advanced and proven problem solving and conflict resolution. Strong attention-to-detail, analytical skills, and ability to concisely summarize large amounts of complex information 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 setsTables Figures and Listings (TFLs)Clinical Trial Transparency deliverables (data de-identification, results posting files) Demonstrated knowledge of Clinical Study Reports and other Clinical Documents BSc in mathematics, statistics, engineering, computer science, or life or social sciences.Desirable
Experience of Operational Excellence, lean principles, processes, tools, behaviours & leadership Demonstrated experience designing and implementing technology solutions and tools. Prior relevant knowledge of a statistical or database programming language (preferably SAS). Medical writing experience, turning Tables Figures and Listings Clinical Study Reports Previous experience as System OwnerDate Posted
05-cze-2024Closing Date
28-cze-2024-
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