Data Management Specialist - Clinical Trials

Ascend Clinical, LLC; Sydney; Hybrid; AUD 90,000 - 130,000; Full time

Benefits offered by this job

Flexible working arrangements

Professional development opportunities

Career progression

Job summary

Ascend Clinical is seeking a Data Management Specialist to join our team on a full-time or part-time basis, with location flexibility across Australia. This role focuses on ensuring data integrity, accuracy and security across trial data, supporting regulatory compliance and scientific validity of our research efforts.

You will design, validate and manage EDC systems and CRFs, monitor data entry, prepare data for analysis, and collaborate with clinical, statistical and regulatory teams.

Qualifications

• Diploma or Bachelor’s degree in life sciences, health sciences, information technology or related discipline.
• Minimum 2 years’ experience in clinical trial data management within a CRO, pharma or academic medical centre.
• Proficiency with EDC systems and clinical trial management software.
• Strong knowledge of GCP, ICH guidelines and regulatory requirements.
• Advanced proficiency in Microsoft Excel and experience with statistical software or DB management tools.
• Excellent attention to detail with the ability to manage complex datasets.

Responsibilities

• Design, develop and maintain EDC systems and CRFs for trials.
• Perform comprehensive data validation, QA checks and verification.
• Create and manage data management plans and SOPs.
• Monitor data entry activities and coordinate with sites to resolve queries.
• Prepare data for statistical analysis and ensure timely database lock.
• Maintain data security and regulatory compliance (GDPR/local law).
• Collaborate with clinical, statistical and regulatory teams.
• Provide training and support to site staff on data processes.
• Generate data management reports and support audit trails.
• Troubleshoot issues with data systems with IT/vendors.

Skills

Data management

Regulatory knowledge

SQL knowledge

Excel

Attention to detail

Communication skills

Team collaboration

Education

Bachelor's degree in life sciences

Diploma in health sciences

Tools

EDC systems

Clinical trial management software

Database management tools

Job description

Data Management Specialist - Clinical Trials

Ascend Clinical is seeking a Data Management Specialist to join our team on a full-time or part time basis - location flexible across Australia. This role is fundamental to the success of our clinical research operations, ensuring the integrity, accuracy and security of data across all trial programmes. As a Data Management Specialist, you will be responsible for overseeing the collection, validation, and management of clinical trial data, directly supporting the regulatory compliance and scientific validity of our research initiatives. This position offers the opportunity to make a meaningful impact on clinical research whilst working with cutting-edge data management systems and methodologies.

What you’ll be doing

• Design, develop and maintain electronic data capture (EDC) systems and case report forms (CRFs) for clinical trials, ensuring compliance with regulatory requirements and international standards
• Perform comprehensive data validation, quality assurance checks and verification to ensure accuracy and completeness of trial data
• Create and manage data management plans, standard operating procedures (SOPs), and documentation for trial protocols
• Monitor data entry activities, identify discrepancies and coordinate with sites to resolve data queries and exceptions
• Prepare data for statistical analysis and ensure database lock compliance with trial timelines
• Maintain data security, confidentiality and regulatory compliance with relevant legislation including GDPR and local privacy requirements
• Collaborate with clinical, statistical and regulatory teams to support study objectives and reporting requirements
• Provide training and support to site staff and trial coordinators on data management processes and systems
• Generate data management reports and support audit trail documentation for regulatory inspections
• Troubleshoot technical issues with data systems and liaise with IT and software vendors for system maintenance

What we’re looking for

• Diploma or Bachelor's degree in life sciences, health sciences, information technology or a related discipline
• Minimum 2 years’ experience in clinical trial data management within a clinical research organisation, pharmaceutical company or academic medical centre
• Proficiency with electronic data capture (EDC) systems and clinical trial management software
• Strong knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines and relevant regulatory requirements
• Advanced proficiency in Microsoft Excel and experience with statistical software or database management tools
• Excellent attention to detail with a demonstrated ability to manage complex datasets and identify errors
• Strong written and verbal communication skills with the ability to work effectively across multidisciplinary teams
• Experience with eClinical systems and programming knowledge (SQL or similar) would be advantageous
• Ability to prioritise multiple tasks, meet strict deadlines and work in a fast-paced environment

About us

Ascend Clinical is a leading clinical research organisation committed to advancing medical science through rigorous, ethical and innovative clinical trials. We partner with medical device innovators and academic institutions to conduct world-class research that ultimately improves patient outcomes. Our team is dedicated to maintaining the highest standards of data integrity, regulatory compliance and scientific excellence. We foster a collaborative, supportive workplace culture where our employees are empowered to develop their expertise and contribute meaningfully to groundbreaking research.

What we offer

• Competitive salary package commensurate with experience and qualifications
• Comprehensive professional development and training opportunities, including support for continuing education and certification programmes
• Flexible working arrangements to support work-life balance
• Collaborative and inclusive workplace culture with a commitment to diversity and equality
• Career progression opportunities within a growing organisation
• Modern workplace facilities and access to the latest clinical trial technology and systems