Clinical Trial Data Manager

Clinical Trial Data Manager

Sinclair Dermatology is a globally recognised medical centre led by the internationally renowned Dermatologist, Professor Rodney Sinclair. We see over 10,000 patients annually and host Australia’s largest Dermatology research and Clinical Trials centre (DIRECT). Our main office is conveniently located in East Melbourne, with a second centre in Pascoe Vale South.

The Opportunity:

We have an exciting opportunity to join our Clinicals Trials team as a Clinical Trial Data Manager. This position is available on a full-time basis. With team fit a priority, we are seeking an experienced and motivated individual with a passion for clinical research.

Position Description

Reporting to the Head of Clinical Trials and Research, the applicant will play a pivotal role in ensuring data management and operational activities are executed in accordance with Good Clinical Practice (GCP) and Good Data Practices (GDP) guidelines, standard operating procedures as well as relevant Australian laws and regulations at DIRECT.

The role

You will be responsible for but not limited to the following duties:

• Develop site-specific documentation on operational processes and data management plans for Clinical Trials as well as other relevant SOPs or guidelines
• Collaborate with the Clinical Trials team to coordinate operational and logistical activities, including patient and doctor scheduling, to ensure the efficient execution of Clinical Trials.
• Participate in the development, testing and implementation of electronic data capture systems (EDC) for investigator-initiated Clinical Trials
• Identify areas for improvement in operational activities and work closely with managers to implement streamlined unit processes.
• Support and improve site’s data management plan and processes, ensuring data entry and query resolution is completed in a timely manner.
• Support site study team in preparation for database locks and interim analyses
• Ensure the accuracy and completeness of Clinical Trial Data entered into EDC
• Review and resolve data discrepancies and data-related issues in collaboration with site study team
• Provide QC reports to Unit Head for relevant studies
• Ensure studies are performed in accordance with GCP guidelines, NHMRC standards, Australian Safety and Quality Framework for Health Care, relevant Australian laws and regulations, site SOPs, and study protocols.

Selection Criteria

Essential

• Appropriate tertiary qualifications (e.g., Science, Nursing, Pharmacy, or related disciplines).
• Minimum 3 years’ experience in a Clinical Trials role
• Sound understanding of Clinical Trials and their phases
• Proven track record in navigating different EDCs and Clinical Trials data query resolution
• Sound knowledge of the National Statement on Conduct of human research, ICH-GCP, data privacy and Good Data Practices.
• High level of organisation and attention to detail.
• Ability to handle multiple tasks and prioritise effectively.
• Familiarity with office-based computer packages such as Microsoft Office with a high- level proficiency in Excel desirable
• Excellent time management skills.
• Team player with high-level oral and written communication skills.
• Understanding of privacy and confidentiality requirements

Additional benefits

• Supportive team environment.
• $90,000 Plus 11.5% superannuation (as of 1 July 2024)
• Flexible working hours.
• Rewarding industry.
• Staff discounts.
• Conveniently located office within proximity to train stations, buses, and trams.
• Working on Weekdays only

Previous applicants do not need to reapply.

Our unit does not operate after hours or on weekends.