Senior Clinical Data Manager - Anywhere in Australia - Remote

About Us Southern Star Research is a full-service Contract Research Organization (CRO) dedicated to navigating the complexities of bringing new medical products to market. With a legacy of excellence that began 14 years ago in Sydney, we have grown from a small, passionate team into a global network of experts committed to delivering high-quality services in medical writing, clinical monitoring, project management, biostatistics, data management, safety and medical monitoring, and quality assurance. Southern Star Research has been recognized for its outstanding contributions to the field, winning prestigious awards such as the Frost and Sullivan 2024 Asia-Pacific Competitive Strategy Leadership Award and being named as Great Place to Work in Australia in 2024 and 2025. Our international team continues to deliver innovative clinical trial solutions across diverse therapeutic areas, ensuring the success of every study we manage. The role Due to ongoing growth, we are looking for an experienced Clinical Data Manager/Senior Clinical Data Manager to join our growing team. We have both permanent and contract opportunities available, with flexibility to be office based, hybrid or fully remote anywhere in Australia. Reporting To The Data Management Team Leader, Responsibilities Are

• Contribute to the design of CRF pages, providing support to the Database Developer
• Act as central point of contact for internal and external stakeholders on assigned studies
• Planning and execution of data management projects in line with company SOPs, collaborating with clients and project teams
• Provide input into the clinical trial protocol to ensure effective data collection and reporting
• Develop plans, checklists, guidelines and training materials, as well as other data management documentation that facilitates effective data collection and review
• Coordinate and undertake UAT of eCRF and consistency checks
• Coordinate preparation of the data management plan, the review of automated consistency check specifications and the preparation of manual review specifications
• Support the mentoring and development of Clinical Data Managers
• Ensure that clinical trial data is reviewed and all issues addressed on a timely and continuous basis. Perform data cleaning including: automated checks, manual checks, lab reconciliation and SAE reconciliation. Supervising Clinical Data Associates assigned to the project.
• Coordinate/perform the medical coding and coding review of coded terms

To be successful in the role, we're looking for candidates with:

• Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines.
• Expert knowledge of in clinical data management and clinical trials, with previous experience within a CRO or pharmaceutical company
• Experience in a wide variety of EDC systems, with Viedoc and Zelta being preferred
• A demonstrated ability to work well in a team, be adaptable and flexible, with a positive attitude and a willingness to learn;
• Superior organisation and planning skills and the ability to deliver work according to study timelines and within the project budget;
• A high level of written and verbal communication skills; and
• An exceptional level of attention to detail

Why Southern Star?

• Join a passionate team committed to our shared purpose to create brighter futures, one study at a time.
• Exciting growth phase, creating ongoing career development opportunities for our teams
• Competitive remuneration
• Flexible work environment, with hybrid and fully remote options
• STAR day - one extra day off per year for you to recharge.

Diversity, Equity and Inclusion At Southern Star Research, we are committed to fostering a safe, inclusive, and respectful workplace where everyone feels valued and empowered to contribute. We celebrate the diversity of our team and recognise the strength that comes from different perspectives, backgrounds, and lived experiences. We are dedicated to ensuring an inclusive recruitment process and providing equal opportunities for all applicants, regardless of race, ethnicity, gender identity, sexual orientation, age, disability, or cultural background.