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.

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Key Responsibilities:

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

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- Bachelor's degree in a relevant field
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- At least 2 years of experience in a similar role within a CRO, pharmaceutical company, biotech, or research institute is preferred
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- Knowledge of clinical data management processes and applicable regulatory standards
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- Familiarity with SAS is an advantage
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- Excellent English communication skills, both written and verbal
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- Good knowledge of Microsoft Office
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- Robust organizational, planning, and problem-solving skills
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- A quality-driven, results-oriented, and collaborative approach
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- Flexibility, adaptability, and an interest in innovation
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What we offer:

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- We offer a competitive salary with other benefits/bonuses
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- Professional development and opportunities to expand your expertise in clinical data management with an expanding and growing company
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- A collaborative and quality-focused working environment
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- The opportunity to work on international clinical research projects
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Please read the information notice on the processing of personal data in the candidate's information section of our company website.

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Who we are:

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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.
n 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.

📌 Clinical Data Manager (New South Wales)
🏢 OPIS
📍 New South Wales