Clinical Data Manager

OPIS s.r.l.; Sydney; On-site; AUD 110,000 - 150,000; 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. 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

We are looking for a Clinical Data Manager to join our team and support the planning, execution, and delivery of data management activities across clinical trials and investigations.

Key Responsibilities

• Prepare and maintain Data Management documentation, including CRFs, Data Management Plans, and data transfer specifications


• Design, develop, and validate paper and electronic Case Report Forms (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

Requirements

• Bachelor's degree in a relevant field


• At least 2 years of experience in a similar role within a CRO, pharmaceutical company, biotech, or research institute is preferred


• Knowledge of clinical data management processes and applicable regulatory standards


• Familiarity with SAS is an advantage


• Excellent English communication skills, both written and verbal


• Good knowledge of Microsoft Office


• Strong organizational, planning, and problem-solving skills


• A quality-driven, results-oriented, and collaborative approach


• Flexibility, adaptability, and an interest in innovation

What we offer

• We offer a competitive salary with other benefits/bonuses


• Professional development and opportunities to expand your expertise in clinical data management with an expanding and growing company


• A collaborative and quality-focused working environment


• The opportunity to work on international clinical research projects

Please read the information notice on the processing of personal data in the candidate's information section of our company website.

Who we are

Founded in 1998 in Italy and now operating at an international level, OPIS is a full-service science driven biotech focused CRO providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.

OPIS added value lies in its highly specialized professionals who can assist their clients using their deep know-how and experience to guarantee a top-quality level of Clinical Trial Management and ability to operate in a wide range of fields (medical writing, scientific and statistical consultancy for trial design, regulatory activities, pharmacovigilance, etc.) always contributing to our clients' challenging achievements.