Clinical Data Manager

Australia·Sydneymid

Clinical Data ManagerLaboratory & Life Sciences

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Quick Summary

Key Responsibilities

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

Requirements Summary

Bachelor’s degree in a relevant field At least 2 years of experience in a similar role within a CRO, pharmaceutical company, biotech,

Technical Tools

Clinical Data ManagerLaboratory & Life Sciences

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.

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