Job Description:
Job Description: Clinical Data Manager Consultant – Science & Pharmaceuticals Job Industry, Perth
The Clinical Data Manager Consultant in Perth is responsible for providing expert guidance and oversight on the management, standardisation, and regulatory compliance of clinical trial data. This consultant role involves strategic planning, data process evaluation, and the optimisation of data management practices across multiple studies and therapeutic areas. The position serves as a key advisor to clinical teams, helping to improve data accuracy, consistency, and readiness for statistical analysis and regulatory submission.
Key duties include developing comprehensive data management plans, establishing data collection guidelines, and ensuring harmonisation across trials. The consultant advises on the selection and configuration of clinical data management systems (CDMS) and electronic data capture (EDC) platforms, working with vendors and internal stakeholders to implement effective, scalable solutions. They may also review CRF designs, build specifications, and edit check logic to ensure alignment with study protocols.
The consultant leads data review meetings, ensures timely query resolution, and supports data cleaning efforts. They provide insight into process improvement, system integration, and data standardisation using CDISC and related frameworks. Their involvement is critical during database lock, helping ensure that the final dataset meets all regulatory and analytical requirements.
The role also involves training clinical teams in data-related procedures, troubleshooting issues, and supporting audits or inspections. Coordination with biostatistics, regulatory affairs, and clinical operations is frequent, ensuring smooth data flow and integrity across all project phases. The consultant may be engaged in designing metrics and dashboards to improve trial oversight and real-time data visibility.
Positioned within Perth’s expanding pharmaceutical and clinical research landscape, this role offers a strategic opportunity to enhance data governance practices across trials. The Clinical Data Manager Consultant brings technical, operational, and compliance-focused expertise that contributes to efficient, high-quality clinical research.
Job Requirement:
Job Requirements: Clinical Data Manager Consultant – Science & Pharmaceuticals Job Industry, Perth
Applicants should have expert-level understanding of clinical data management workflows and systems such as Medidata Rave, Veeva CDMS, or Oracle InForm. Familiarity with EDC setup, edit check development, and study-specific validation plans is crucial. The consultant must be capable of critically reviewing case report forms and ensuring proper data mapping and collection methods.
Proficiency in clinical data standards, particularly CDISC formats like SDTM and ADaM, is required to ensure consistency and support downstream statistical analysis. Experience with data listings, discrepancy management, and coding dictionaries such as MedDRA and WHO Drug is necessary. A working knowledge of regulatory standards like GCP, 21 CFR Part 11, and ICH E6 is essential for audit preparedness.
Excellent consulting and advisory skills are needed to assess existing data management processes and suggest workflow enhancements. Candidates should demonstrate strategic thinking and an ability to align clinical data practices with organisational goals. Project management abilities are critical for overseeing study timelines, deliverables, and system rollouts.
Strong interpersonal and communication skills are necessary to interact effectively with sponsors, CROs, clinical teams, and software vendors. The ability to train and support staff in best practices and system usage is also essential. Documentation skills must be strong, particularly in preparing SOPs, training guides, and audit materials.
The ideal candidate will show initiative in exploring new data tools, promoting digital transformation in clinical research, and driving data accuracy from the point of entry to final analysis. A detail-oriented and process-driven mindset will ensure continuous improvement across all aspects of data management in this consulting role.
