Job Title

Care to join the Team? GC CRO is a full-service oncology CRO specialising in radiopharmaceutical development. We help pharma and biotech companies accelerate drug development, facilitate collaborative research efforts, bridge the translational gap, enhance diagnostic capabilities, and engage a global network of medical experts. Refer to our website for more detailed information: We are currently looking a Clinical Data Manager for the CRO division of the business, this role will be critical in ensuring the integrity and quality of clinical trial data. As a key member of our team, you will collaborate closely with Senior Clinical Data Managers and other project team members to support and lead various data management activities. Your role will involve reviewing and maintaining clinical data, ensuring compliance with Good Clinical Practice (GCP), receiving training in electronic data capture (EDC) systems, and fostering clear communication with both internal teams and external vendors. On offer is a permanent full-time position, working remotely from anywhere within Australia. More Specifically, you will: Support the Senior Clinical Data Managers with all data management activities from study start-up to database lock Review of Case Report Forms, Edit Checks, Data Management Listings, Query Listings for data cleaning Provide ongoing identification and resolution of errors and inconsistencies in the clinical trial data to ensure high quality data Create, review, and maintain global working practices, standards and templates to support Good Clinical Practice (GCP) inspection readiness Lead training on electronic systems for the study including EDC and IRT system Provide clear verbal or written communication and hands-on support to project team members and to sub-CROs/vendors related to CRF design, data quality and reporting of study results Ensure data integrity across projects following applicable regulatory standards, ICH, GCP and SOP Monitor data clean-up process, including where performed by sub-CROs/vendors, from study start-up through data archiving Manage activities including medical coding, developing data validation checks, and managing database snapshots Prepare and distribute project status reports to project team and management. We''re interested in hearing from people who have: Tertiary qualifications in a scientific or IT-related field e.g. IT Computer Science 3 years experience supporting clinical data collection, clinical data coordination in a pharmaceutical/biotech/CRO environment Must have experience with Electronic Data Capture systems Experience with clinical data registries is preferable Knowledge of clinical research, medical terminology/disease processes and clinical practice Understanding of GCP, ICH and other regulatory requirements Strong clinical systems understanding Experience with common project management methodologies Ability to write, collate and present reports Benefits of joining our team: Own your development, learn every day. Opportunities to be exposed to getting involved in early site engagement right from feasibility and start up period to build relationship with site. Opportunities to work directly with sponsor on assigned projects. Internal and external training and development opportunities. All employees and their family members have access to free confidential support that is completely external to GenesisCare including financial, nutritional and wellbeing coaching, legal advice & counselling. Enhance your holistic wellbeing with our Full Circle wellbeing program. Range of benefits available: Qantas membership discount, Anytime Fitness Gym membership discount, 12 weeks paid parental leave, Bupa discount. About GenesisCare By joining GenesisCare, you will be joining a highly progressive and passionate team of healthcare professionals and support staff, united by a common purpose: to design care experiences that deliver the best possible life outcomes. The ambition for better cancer care that began our story, has grown into a passionate team of ~2,000 employees across 50 locations nationally. Join us to design better care and enjoy a career with purpose.