Clinical Data Manager

opissrl; Sydney; On-site; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive salary and benefits

Professional development opportunities

Collaborative working environment

International project exposure

Job summary

OPIS is seeking a Clinical Data Manager to support planning, execution, and delivery of data management activities across clinical trials and investigations. Responsibilities include creating and maintaining CDMPs, CRFs, and data transfer specs, and ensuring regulatory compliance.

The role requires a Bachelor's degree and at least 2 years in a similar CRO/pharma setting, with strong English communication and proficiency in Microsoft Office.

Qualifications

• Bachelor's degree in a relevant field.
• Minimum 2 years' experience in a CRO/pharma or related role.
• Knowledge of clinical data management processes and regulatory standards.
• Experience with SAS is advantageous.
• Excellent English communication, written and verbal.
• Proficient in Microsoft Office.
• Strong organizational and problem-solving skills.
• Quality-driven, collaborative attitude and adaptability.

Responsibilities

• Prepare and maintain Data Management documentation, including CRFs, Data Management Plans, and data transfer specifications
• Design, develop, and validate paper and electronic 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

Skills

Data management

English communication

Organizational skills

Problem solving

Collaborative approach

Education

Bachelor's degree in a relevant field

Tools

SAS

EDC systems

Microsoft Excel

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.