- Location
- Sydney
- Type
- Full-time
- Department
- Healthcare
- Seniority
- Manager
- Experience
- 2+ years
- Closing date
- Today
- Source
- ApplyToJob
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:
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.
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
- 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
- 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
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.
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Pivacy Policy
Skills
Clinical Trials
