Associate Director, Global Clinical Operations Data Management

Summary

Join Telix Pharmaceuticals as an Associate Director, Global Clinical Operations Data Management, contributing to the international rollout of a prostate cancer imaging agent and the advancement of late clinical-stage products. You will be responsible for clinical data stewardship, ensuring data integrity and compliance with regulatory standards. Key responsibilities include managing data transfers, developing data management procedures, providing training, and collaborating with cross-functional teams. The ideal candidate possesses a Bachelor's degree (or equivalent) in a relevant field, 9+ years of clinical trial data management experience (including 3-5 years managing imaging data), and 4+ years of leadership experience. Telix offers competitive salaries, bonuses, equity incentives, generous vacation time, paid wellness days, and support for learning and development.

Requirements

• Bachelor’s degree in Health Information Management, Life Sciences or equivalent work experience
• 9+ years of experience in clinical trial data management
• 3 to 5 years’ experience managing imaging data
• 4+ years of leadership experience
• Demonstrated understanding of GCP and applicable national and international regulations guiding research and health information management
• Experience in the use of Electronic Data Capture (EDC) Software, electronic Trial Master File (eTMF) and imaging storing softwares
• Accuracy, strong attention to detail, highly developed organisational skills and proven ability to establish priorities, manage tasks, exercise sound judgement and work to multiple, tight and conflicting deadlines
• Highly developed organisational skills and proven ability to establish and manage competing priorities and manage multiple strict deadlines and manage competing priorities
• Excellent interpersonal, verbal and written communication skills with sound negotiating and conflict resolution skills and a demonstrated level of tact and discretion
• Demonstrated ability to work productively both independently and as part of a team, taking initiative and exercising sound judgement in resolving matters that may arise as part of normal daily work
• Knowledge of patient/clinical confidentiality protocols

Responsibilities

• Manage clinical trial data in compliance with regulatory standards including but not limited to International Conference on Harmonisation - Good Clinical Practice (ICH-GCP), European Medicines Agency (EMA) guidelines for data archival, and 21CFR Part 11 and Part 312
• Ensure data accuracy, completeness, and consistency throughout the data lifecycle
• Serve as a steward of clinical trial data, overseeing data quality, integrity, and security
• Develop and implement data governance processes to maintain high-quality data
• Coordinate data transfers between external vendors and the sponsor organization
• Ensure that data transfers comply with regulatory requirements, including 21CFR Part 11 and Part 312, and are conducted securely and efficiently
• Maintain comprehensive documentation of data management activities and ensure compliance with regulatory guidelines, including 21CFR Part 11 and Part 312, and internal SOPs
• Develop procedures for the collection, archival, and management of imaging data in clinical trials
• Ensure compliance with regulatory standards and industry best practices for imaging data
• Develop and/or update processes and procedures related to data management and transfer
• Provide training and support to team members and external stakeholders on data management processes, guidelines, and best practices
• Conduct training sessions to ensure understanding and adherence to data management protocols
• Perform data quality checks, identify discrepancies or issues, and implement corrective actions as needed
• Conduct audits and inspections to ensure data integrity and compliance
• Collaborate with cross-functional teams including clinical operations, biostatistics, and regulatory affairs to ensure alignment on data management processes and requirements
• Contributes to the development of the Data Management Plan and associated documents
• Performs other duties as assigned

Preferred Qualifications

• Advanced degree
• Experience in process mapping and improvement

Benefits

• Competitive salaries
• Annual performance-based bonuses
• An equity-based incentive program
• Generous vacation
• Paid wellness days
• Support for learning and development