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Associate Director, Clinical Document Anonymization Technology, Clinical Trial Transparency, Warsaw

Client:

Location: Warsaw, Poland

Job Category: Other

EU work permit required: Yes

Job Reference: 879c93cf79fb

Job Views: 19

Posted: 23.01.2025

Expiry Date: 09.03.2025

Job Description:

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 requires 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 manages 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 promoter and communicator of a “transparency mindset.”
• Participates and coordinates 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.
• 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.
• Participates in forward-thinking efforts around proactive writing of CSRs to support automated anonymization.
• Ensures adherence to all applicable AstraZeneca and external requirements.
• Establishes best practices 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 pressure.
• 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.
• Demonstrated knowledge of Clinical Study Reports and other Clinical Documents.
• BSc in mathematics, statistics, engineering, computer science, or life or social sciences.
• 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.

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