Clinical Data Manager
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Job Description
Clinical Data Manager overseeing clinical trial data quality, EDC builds, and database lock activities. Supporting Telix Pharmaceuticals’ precision radiopharmaceuticals for cancer and rare diseases.
Responsibilities:
- Ensure the integrity, accuracy, and compliance of clinical trial data with study and regulatory requirements, SOPs, and CDISC data standards
- Oversee data quality for Telix clinical trials
- Ensure EDC development meets study requirements
- Oversee data cleaning activities and manage external data transfers
- Lead data management activities for assigned clinical trials from study start-up through database lock and study close-out
- Optimize data collection, flow, and access across EDC and non-EDC sources
- Act as primary data management subject matter expert for assigned trials
- Oversee EDC build activities, including DMPs, data review plans, specifications, UAT, and eCRF completion guidelines
- Oversee data entry, cleaning activities, and eTMF data management documentation
- Liaise with external vendors regarding timelines, deliverables, and data transfers
- Assist with review of data-related deliverables and development/review of protocols and SAPs
- Support audits, inspections, study kick-off meetings, and internal Clinical Data Management initiatives
- Ensure compliance with GCP, CDISC standards, and applicable regulations
Requirements:
- Bachelor’s degree in Health Information Management, Life Sciences or equivalent work experience
- Advanced degree preferred
- 3+ years of experience in clinical trial data management
- Minimum of 1 year of experience independently leading data management activities for complex global clinical trials
- Ability to oversee multiple vendors and manage strict timelines for multiple global complex clinical trials
- Experience creating eCRF specifications, edit check specifications, Data Management Plans, Data Review Plans, eCRF Completion Guidelines, UAT plans and test scripts, and data transfer agreements
- Accuracy, strong attention to detail, highly developed organizational skills, prioritization, sound judgment, and ability to manage multiple tight and conflicting deadlines
- Ability to work independently and as part of a team
- Knowledge of CDISC, SDMT, CDASH, GCP and other regulatory requirements for global clinical trials
- Knowledge of collaborative functions and activities of global clinical trials
- Some travel (20%) may be required, potentially over weekends
- Strong communication, collaboration, adaptability, ethical behavior, resilience, and commitment to continuous learning
Benefits:
- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
- Hybrid and remote work arrangements are available at Telix
- Equal opportunity employment
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