Global-Impact Clinical Data Manager

Opis; New South Wales; On-site; AUD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

Job summary

OPIS seeks a Clinical Data Manager to join our expanding team and support planning, execution, and delivery of data management across clinical trials and investigations. You will prepare documentation, design CRFs, and ensure data quality in line with regulatory standards.

The role requires a Bachelor’s degree and at least two years in a similar CRO/biotech setting, strong English communication, and MS Office proficiency.

Qualifications

• Bachelor's degree in a relevant field.
• At least 2 years of experience in a similar role within CRO/pharma/biotech/research institute preferred.
• Knowledge of clinical data management processes and regulatory standards.
• Familiarity with SAS is an advantage.
• Excellent English communication skills (written and verbal).
• Good knowledge of Microsoft Office.
• Strong organizational, planning, and problem-solving skills.
• Quality-driven, results-oriented and collaborative approach.
• Flexibility, adaptability, and interest in innovation.

Responsibilities

• Prepare and maintain Data Management documentation (CRFs, Data Management Plans, data transfer specs).
• Design, develop, and validate CRFs and clinical databases (paper and electronic).
• Perform data cleaning, medical coding, SAE reconciliation, and QC activities.
• Manage database changes and support freeze and lock activities.
• Ensure data management complies with regulations and CDISC standards.
• Collaborate with Sponsors, study teams, and external stakeholders for timely delivery.
• Monitor study milestones, KPIs, and deliverables.
• Maintain project documentation and training/activity tracking.

Skills

Data management

Clinical trials

Regulatory awareness

English communication

MS Office

Problem-solving

Team collaboration

Innovation

Education

Bachelor's degree

Tools

SAS

Job description

OPIS seeks a Clinical Data Manager to join our expanding team and support planning, execution, and delivery of data management across clinical trials and investigations. You will prepare documentation, design CRFs, and ensure data quality in line with regulatory standards.

The role requires a Bachelor’s degree and at least two years in a similar CRO/biotech setting, strong English communication, and MS Office proficiency.