Clinical Data Operations Lead

6 months ago

Sydney, Australia Telix Pharmaceuticals (APAC) Full time

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. **At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. **You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

As the Clinical Data Operations Lead, you will serve as the clinical data steward, playing a pivotal role in maintaining the integrity, quality, and compliance of clinical trial data throughout its lifecycle. You will collaborate closely with our internal clinical team and external organizations to ensure accurate data management and facilitate multi-center data collation. Your keen attention to detail, excellent organizational skills, and ability to prioritize tasks will be key to your success in this role.

**What you'll do**
- 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.
- 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.
- Maintain comprehensive documentation of data management activities and ensure compliance with regulatory guidelines.
- Develop procedures for the collection, archival, and management of imaging data in clinical trials.
- Provide training and support to team members and external stakeholders on data management processes, guidelines, and best practices.
- 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.

**About you**
- Ideally 5 or more years of experience in clinical trial data management and at least 3 years' experience managing imaging data.
- Qualifications in Health Information Management, Life Sciences or equivalent highly desirable.
- 5+ years' experience in process mapping and improvement.
- 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.
- Knowledge of patient/clinical confidentiality protocols.
- Attention to detail, highly developed organisational skills and proven ability to establish priorities and manage tasks.
- Demonstrated ability to work productively both independently and as part of a team.

**Why work at Telix?**

At Telix, we believe **everyone counts**, **we strive to be extraordinary**, and **we pursue our goals with determination and integrity**. You will be part of an engaged and supportive group of colleagues who all have a shared** purpose: to help people with cancer and rare diseases live longer, better quality lives. **Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world.** **We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

VIEW OUR PRIVACY POLICY HERE

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