Clinical Data Manager

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Telix Pharmaceuticals Limited

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2015

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Telix Pharmaceuticals Limited is a commercial-stage biopharmaceutical company dedicated to transforming the way cancer and rare diseases are diagnosed and treated. Focusing on the development and commercialization of theranostic radiopharmaceuticals, Telix utilizes targeted radiation to enhance treatment decision-making and deliver personalized therapy. With an extensive pipeline addressing areas such as prostate and kidney cancer, neuro-oncology, and musculoskeletal cancers, Telix has garnered global regulatory approvals for its lead imaging agent, Illuccix®, and is actively conducting numerous clinical trials worldwide.

📋 Description

• 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