OPIS s.r.l.
Clinical Data Manager
Full-TimeUpdated on 9/28/2026
No salary listed
Junior
Bachelor's
Australia
In Person
About the job
Requirements
- A bachelor's degree in a relevant field is required.
- Knowledge of clinical data management processes and applicable regulatory standards is required.
- Excellent written and verbal English communication skills are required.
- Good knowledge of Microsoft Office is required.
- Strong organizational, planning, and problem-solving skills are required.
- A quality-driven, results-oriented, and collaborative approach is required.
- Flexibility, adaptability, and an interest in innovation are required.
Responsibilities
- Prepare and maintain data management documentation, including Case Report Forms, Data Management Plans, and data transfer specifications.
- Design, develop, and validate paper and electronic Case Report Forms and clinical databases.
- Perform data cleaning, medical coding, Serious Adverse Event reconciliation, and quality control activities.
- Manage database changes and support database freeze and lock activities.
- Ensure data management activities comply with applicable regulations and Clinical Data Interchange Standards Consortium standards.
- Collaborate with sponsors, study teams, and external stakeholders to ensure timely project delivery.
- Monitor study milestones, key performance indicators, and deliverables.
- Maintain accurate project documentation and ensure timely completion of training and activity tracking.
Desired Qualifications
- At least 2 years of experience in a similar role within a contract research organization, pharmaceutical company, biotechnology company, or research institute is preferred.
- Familiarity with SAS is advantageous.