Clinical Data Manager

The Role:

The successful candidate will perform and oversee data management activities in order to provide high quality data that meets client/project needs. Ensures that data is processed and tracked in alignment with regulatory and quality standards. We need people with technical CRF design capabilities for our studies with Medidata Rave database build experience.  This role could be based in Sydney, Melbourne, Brisbane, Adelaide or Perth.

Key Responsibilities:

• Serve as Data Team Lead (DTL) on a program of 6-10 global clinical trials or 40+ increasingly complex central laboratory studies
• Serve as Data Operations Coordinator (DOC) for one or three global clinical trials with fewer than 25 operations staff (excludes DE) or 20-40 central laboratory studies, or serve in a leadership role to a specific DM Task.
• Serve as a Subject Matter Expert (SME)
• Provide leadership and expertise in a specific CDM task or technology
• Manage delivery of projects through full data management process life-cycle.
• Provide justification for customer negotiations.
• May serve as Project Manager for single service data management projects.
• Manage comprehensive data management tasks pertaining to the documented project specifications.
• Manage comprehensive quality control procedures.
• Provide data management expertise and data management process improvement to CDM management.
• Mentor other team members in training and developing data management expertise.
• Independently bring project solutions to the CDM team and the CDM Department.
• Manage a focus team or a best practice team

• Manage the development and implementation of new technology/tool.
• Present at professional conferences and/or publish articles in professional journals.
• Provide CDM with technical expertise.
• Develop and maintain good communications and working relationships with CDM and project teams.

Key requirements:

• Bachelor's degree in clinical, biological or mathematical sciences, or related field or a nursing qualification
• 5 years relevant experience including proven competence in managing delivery of multiple projects simultaneously through full data management study life-cycle, including large trials >1000 patients, and including experience handling customer negotiations (e.g. bid defence meetings)
• Thorough knowledge of the data management process and experience in specialized data management skills (e.g., therapeutic, extensive knowledge, SAE reconciliation, central laboratory, and/or new technology
• Knowledge of operating procedures and work instructions and the ability to apply them in practice
• Excellent experience and organizational, communication, and demonstrated expert data management skills
• Comprehensive understanding of clinical drug development process (detail oriented)
• Ability to establish and maintain effective working relationships with co-workers, managers and clients

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.