Associate Director, Global Clinical Operations Data Management

See Yourself at Telix

Under the direction of the VP of Global Clinical Operations the role must successfully deliver all data management deliverables, meeting internal and external Company Objectives. 

The Associate Director, Global Clinical Operations Data Management will act as the clinical data steward and play a crucial role in ensuring the integrity, quality, and compliance of clinical trial data throughout its lifecycle. The Associate Director, Global Clinical Operations Data Management role will be responsible for understanding and implementing regulatory guidelines, developing processes and procedures for data transfers, storage and maintenance, managing data transfers, and serving as a steward of data quality and integrity.

The role will work closely with our internal clinical team and external organisations to maintain accurate data and facilitate multi-centre data collation.

Key Accountabilities:

• Data Management and Integrity: 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.
• Data Stewardship: 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.
• Data Transfer Management: 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.
• Documentation and Compliance: Maintain comprehensive documentation of data management activities and ensure compliance with regulatory guidelines, including 21CFR Part 11 and Part 312, and internal SOPs.
• Development of Procedures for Collection of Images and Imaging Data: 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.
• Development of Procedure for Clinical Data Collection, Archival and Management: Develop and/or update processes and procedures related to data management and transfer.
• Training and Support: 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.
• Quality Assurance: Perform data quality checks, identify discrepancies or issues, and implement corrective actions as needed. Conduct audits and inspections to ensure data integrity and compliance.
• Collaboration: 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

Education and Experience:

• Bachelor’s degree in Health Information Management, Life Sciences or equivalent work experience. Advanced degree preferred.
• 9+ years of experience in clinical trial data management; 3 to 5 years’ experience managing imaging data.
• 4+ years of leadership experience.
• Experience in process mapping and improvement, preferred.
• 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. 

Key Capabilities:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected.
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behaviour: Act with integrity and demonstrate a commitment to ethical behaviour in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills