Clinical Data Manager

GenesisCare; United States; Remote; USD 80,000 - 110,000; Full time

Job summary

GenesisCare seeks a Clinical Data Manager for their CRO division to ensure the integrity and quality of clinical trial data. This pivotal role involves close collaboration with senior team members, management of data processes, and compliance with regulatory standards, offering a remote position with a focus on professional development.

Benefits

Internal and external training opportunities

Free confidential support for employees and families

Full Circle wellbeing program

Qantas membership discount

Gym membership discount

12 weeks paid parental leave

Bupa discount

Qualifications

• Minimum of 3 years' clinical data management experience.
• Hands-on experience with EDC systems like Viedoc or Medidata Rave.
• Strong understanding of clinical research processes and regulatory requirements.

Responsibilities

• Collaborate with Senior Clinical Data Managers to execute data management activities.
• Review Case Report Forms and support data cleaning processes.
• Maintain compliance with Good Clinical Practice (GCP).

Skills

Data management

Communication

Regulatory compliance

Problem-solving

Education

Degree in a scientific, health-related, or IT discipline

Tools

Electronic Data Capture (EDC) systems

Job description

At GenesisCare we want to hear from people who are as passionate as we are about innovation and working together to drive better 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, bridge 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 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:

• Collaborate with Senior Clinical Data Managers to execute all 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.
• Oversee the query management process and perform 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).
• Lead or support the design and UAT of EDC 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-related, 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 (EDC) system (e.g., Viedoc, Medidata Rave, Veeva, 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 within a clinical data context.
• Strong written and verbal communication skills, with the ability to interface effectively with sponsors, vendors, and cross-functional teams.

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

GenesisCare is an Equal Opportunity Employer.