Clinical Data Manager — Global Trials & Data Excellence

OPIS; Sydney; On-site; AUD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

Professional development

Collaborative environment

International projects

Job summary

OPIS is seeking a Clinical Data Manager to support planning, execution, and delivery of data management activities across clinical trials and investigations.

The role involves preparing documentation, designing CRFs and databases, data cleaning, and ensuring regulatory compliance. A bachelor’s degree and at least 2 years in CRO/biotech are preferred, with strong English and MS Office skills. Join a growing, internationally active biotech CRO.

Qualifications

• Bachelor’s degree in a relevant field.
• At least 2 years of CRO/biotech experience preferred.
• Knowledge of clinical data management processes and regulatory standards.
• Familiarity with SAS is an advantage.
• Excellent English communication, written and verbal.
• Proficient in Microsoft Office.
• Strong organizational, planning, and problem-solving skills.
• Quality-driven, collaborative approach.
• Flexible, adaptable, and innovative mindset.

Responsibilities

• Prepare and maintain Data Management documentation (CRFs, DMPs, data transfer specs).
• Design, develop, validate paper and electronic CRFs and databases.
• Perform data cleaning, medical coding, SAE reconciliation, quality control.
• Manage database changes and support freeze/lock activities.
• Ensure data management complies with regulations and CDISC standards.
• Collaborate with Sponsors and study teams to ensure timely delivery.
• Monitor study milestones, KPIs and deliverables.
• Maintain project documentation and track training/activities.

Skills

Clinical data management

SAS

Microsoft Office

English communication

Organizational skills

Problem solving

Collaboration

Adaptability

Education

Bachelor’s degree in a relevant field

Job description

OPIS is seeking a Clinical Data Manager to support planning, execution, and delivery of data management activities across clinical trials and investigations.

The role involves preparing documentation, designing CRFs and databases, data cleaning, and ensuring regulatory compliance. A bachelor’s degree and at least 2 years in CRO/biotech are preferred, with strong English and MS Office skills. Join a growing, internationally active biotech CRO.