Global Clinical Data Manager: Trials & Data Quality

OPIS s.r.l.

Sydney

On-site

AUD 110,000 - 150,000

Full time

5 days ago
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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. You will prepare and maintain DM documentation, design CRFs and databases, and ensure data quality.

The role requires a bachelor’s degree and at least 2 years in a similar CRO/pharma setting, with knowledge of CDISC standards and SAS advantageous, and strong English communication.

Qualifications

  • Bachelor's degree in a relevant field.
  • 2+ years in a similar CRO/pharma role preferred.
  • Knowledge of clinical data management processes and regulatory standards.
  • SAS knowledge is an advantage.
  • Excellent English communication skills, written and verbal.
  • Strong organizational, planning and problem-solving abilities.
  • Quality-driven, collaborative mindset with adaptability.

Responsibilities

  • Prepare and maintain Data Management documentation including CRFs and Data Management Plans.
  • Design and validate CRFs and clinical databases.
  • Perform data cleaning, medical coding, SAE reconciliation, and quality control.
  • Manage database changes and support freeze/lock activities.
  • Ensure compliance with regulations and CDISC standards.
  • Collaborate with Sponsors, study teams, and external stakeholders.
  • Monitor study milestones, KPIs, and deliverables.
  • Maintain project documentation and training/activity tracking.

Skills

Data management
SAS
Microsoft Office
English communication
Organizational skills
Problem solving
Collaboration

Education

Bachelor's degree

Tools

SAS

Job description

OPIS is seeking a Clinical Data Manager to support planning, execution and delivery of data management activities across clinical trials. You will prepare and maintain DM documentation, design CRFs and databases, and ensure data quality.

The role requires a bachelor’s degree and at least 2 years in a similar CRO/pharma setting, with knowledge of CDISC standards and SAS advantageous, and strong English communication.

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