Clinical Data Manager

GenesisCare; Sydney; On-site; AUD 90,000 - 130,000; Full time

Job summary

GenesisCare CRO in Australia is seeking a Clinical Data Manager to join our CRO team. You will support data management across the study lifecycle, ensure data integrity, and help regulatory compliance to ensure trial data is ready for analysis.

You will work with Senior Clinical Data Managers and project teams, review CRFs and data listings, lead training on EDC and IRT, and coordinate data management activities with external vendors.

Qualifications

• 3+ years' experience in clinical data management.
• Experience with EDC systems.
• Knowledge of GCP, ICH and regulatory requirements.

Responsibilities

• Review CRFs, edit checks, data listings and queries to support data cleaning.
• Identify and resolve data errors and inconsistencies to maintain high-quality data.
• Lead training and provide support on electronic study systems, including EDC and IRT.
• Monitor data clean-up activities and ensure data integrity in line with regulatory requirements and SOPs.
• Support activities including medical coding, data validation checks, database snapshots and project reporting.

Skills

EDC systems

Data management

GCP/ICH knowledge

Communication

Cross-functional collaboration

Education

Tertiary qualification in science/IT

Tools

EDC software

Job description

Job Type: Permanent position | Full time position

Job Description

Care to join the team? Are you passionate about clinical research and ensuring the quality and integrity of clinical trial data? GenesisCare is looking for a Clinical Data Manager to join our Contract Research Organisation (CRO) team in Australia.

GenesisCare CRO is a full-service oncology CRO specialising in radiopharmaceutical development, working with pharmaceutical and biotech organisations to help accelerate drug development and advance medical research. As Clinical Data Manager, you will work closely with Senior Clinical Data Managers and broader project teams to support high-quality clinical data management across the study lifecycle. You’ll play an important role in maintaining data integrity, supporting regulatory compliance and ensuring clinical trial data is accurate, complete and ready for analysis.

What you’ll do:

Support clinical data management activities from study start-up through to database lock. Review CRFs, edit checks, data listings and queries to support effective data cleaning.

Identify and resolve data errors and inconsistencies to maintain high-quality clinical trial data. Support the design and maintenance of eCRFs, Data Management Plans, validation specifications and other study documentation. Coordinate data management activities across study teams and external vendors.

Lead training and provide support on electronic study systems, including EDC and IRT. Monitor data clean-up activities and ensure data integrity in line with GCP, ICH, regulatory requirements and SOPs. Support activities including medical coding, data validation checks, database snapshots and project reporting.

What you’ll bring:

Tertiary qualifications in a scientific or IT-related discipline. At least 3 years’ experience supporting clinical data collection or clinical data coordination within a pharmaceutical, biotech or CRO environment.

Experience working with Electronic Data Capture (EDC) systems. Knowledge of clinical research, medical terminology and clinical practice. Understanding of GCP, ICH and relevant regulatory requirements.

Strong clinical systems knowledge and an understanding of project management methodologies. Excellent attention to detail, problem-solving and critical-thinking skills. Strong communication and relationship-building skills, with the ability to work effectively across multidisciplinary teams and external vendors.

Benefits of joining our team:

Work within a specialised oncology CRO and contribute to clinical research that has the potential to improve patient outcomes. Collaborate with experienced clinical research, data and technology professionals.

Be part of an organisation committed to innovation, quality and evidence-based care. Access opportunities for ongoing learning and professional development. Join a team connected by a shared purpose: to design care experiences that deliver the best possible life outcomes

About GenesisCare CRO

People centricity is at the heart of what we do whether that person is a patient, a referring doctor, a partner or someone in our team. We aim to build culture of care that is patient focused, and performance driven.

Our people promise is "do your life's best work, by always growing, having a profound human impact and making great things happen together." If you'd like to make a difference, join us at GenesisCare CRO. For more information, please refer to our website: https://www.genesiscare.com/cro