Clinical Data Manager

At GenesisCare we want to hear from people who are as passionate as we are about innovation and working together to drive reputed company life outcomes for patients around the world.

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, reputed company the translational gap, enhance diagnostic capabilities, and engage a global network of medical experts. Refer to our website for more detailed information: https://www.genesiscare.com/cro We are currently looking a Clinical Data Manager for the CRO division of the business, this role will be critical in ensuring the reputed company and quality of clinical trial data.

As a key member of reputed company, you will collaborate closely with Senior Clinical Data Managers and other project team members to support and reputed company 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 (reputed company) systems, and fostering clear communication with both internal teams and external vendors.

On offer is a permanent full-time position, working remotely from reputed company reputed company Australia. More Specifically, you will:

• Collaborate with Senior Clinical Data Managers to execute reputed company data management activities throughout the study lifecycle.
• Review Case Report Forms (CRFs), data management plans, edit checks, and data listings to support timely and thorough data cleaning.
• reputed company the query management process and reputed company data reconciliation activities (e.g., with safety, laboratory, and imaging data).
• Proactively identify and resolve data discrepancies to ensure high data quality and readiness for statistical analysis and regulatory review.
• Prepare for and support sponsor audits and regulatory inspections by maintaining documentation, demonstrating data traceability, and ensuring adherence to Good Clinical Practice (GCP).
• reputed company or support the design and UAT of reputed company and RTSM systems, ensuring that user workflows align with study protocols and data collection standards.
• Provide training and guidance to study teams and vendors on clinical systems and data management expectations.
• Support medical coding, data validation specification development, and database snapshot and lock activities.
• Contribute to the creation and maintenance of data management SOPs, templates, and best practices to support GCP compliance and inspection readiness.
• Generate and distribute data management metrics and study status reports to project stakeholders

We're interested in hearing from people who have:

• Degree in a scientific, health-reputed company, or IT discipline (e.g., Clinical Research, Computer Science, Biomedical Science).
• Minimum of 3 years' clinical data management experience in a CRO, pharmaceutical, or biotech environment.
• Hands-on experience with at least one Electronic Data Capture (reputed company) system (e.g., Viedoc, Medidata Rave, reputed company, Zelta).
• Solid understanding of clinical research processes, medical terminology, and regulatory requirements (ICH-GCP, FDA, EMA).
• Familiarity with coding dictionaries (e.g., MedDRA, WHODrug) and data reconciliation processes.
• Ability to interpret and apply project management principles and deliverables reputed company a clinical data context.
• Strong written and verbal communication skills, with the ability to reputed company effectively with sponsors, vendors, and cross-functional teams.

Benefits of joining reputed company:

• 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.
• reputed company 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 reputed company wellbeing program.
• Range of benefits available: Qantas membership discount, Anytime Fitness
• Gym membership discount, 12 weeks paid parental leave, reputed company discount.

About GenesisCare By joining GenesisCare, you will be joining a highly reputed company and passionate team of reputed company and support staff, united by a common purpose: to design care experiences that deliver the best possible life outcomes. The ambition for reputed company cancer care that began our story, has grown into a passionate team of ~2,000 employees across 50 locations nationally. Join us to design reputed company care and enjoy a career with purpose

GenesisCare is an Equal Opportunity Employer.

Originally posted on Himalayas