Clinical Data Manager: CDISC & Trial Data Lead

opissrl; Sydney; On-site; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive salary and benefits

Professional development opportunities

Collaborative working environment

International project exposure

Job summary

OPIS is seeking a Clinical Data Manager to support planning, execution, and delivery of data management activities across clinical trials and investigations. Responsibilities include creating and maintaining CDMPs, CRFs, and data transfer specs, and ensuring regulatory compliance.

The role requires a Bachelor's degree and at least 2 years in a similar CRO/pharma setting, with strong English communication and proficiency in Microsoft Office.

Qualifications

• Bachelor's degree in a relevant field.
• Minimum 2 years' experience in a CRO/pharma or related role.
• Knowledge of clinical data management processes and regulatory standards.
• Experience with SAS is advantageous.
• Excellent English communication, written and verbal.
• Proficient in Microsoft Office.
• Strong organizational and problem-solving skills.
• Quality-driven, collaborative attitude and adaptability.

Responsibilities

• Prepare and maintain Data Management documentation, including CRFs, Data Management Plans, and data transfer specifications
• Design, develop, and validate paper and electronic CRFs and clinical databases
• Perform data cleaning, medical coding, SAE reconciliation, and quality control activities
• Manage database changes and support database freeze and lock activities
• Ensure data management activities comply with applicable regulations, CDISC standards, etc.
• Collaborate with Sponsors, study teams, and external stakeholders to ensure timely project delivery
• Monitor study milestones, KPIs, and deliverables
• Maintain accurate project documentation and ensure timely completion of training and activity tracking

Skills

Data management

English communication

Organizational skills

Problem solving

Collaborative approach

Education

Bachelor's degree in a relevant field

Tools

SAS

EDC systems

Microsoft Excel

Job description

OPIS is seeking a Clinical Data Manager to support planning, execution, and delivery of data management activities across clinical trials and investigations. Responsibilities include creating and maintaining CDMPs, CRFs, and data transfer specs, and ensuring regulatory compliance.

The role requires a Bachelor's degree and at least 2 years in a similar CRO/pharma setting, with strong English communication and proficiency in Microsoft Office.