Job Title: Clinical Trial Project Manager
About the Role
This is a part-time (0.4 FTE), 12 months contract opportunity with possibility of extension. The successful candidate will be responsible for managing all aspects of the trial which is actively recruiting.
Key Responsibilities:
* Implement and review the clinical trial protocol, SOPs and study manuals in accordance with ICH/GCP guidelines and applicable regulations.
* Manage trial budgets, timelines, and resources to ensure the timely execution of the trial.
* Ensure compliance with regulatory requirements, including the review of study reports, clinical data, and documentation.
* Coordinate study team meetings and provide regular updates to stakeholders.
* Develop and manage relationships with clinical investigators, site staff and key stakeholders to ensure successful enrolment and execution of the trial.
* Complete ongoing and ad hoc reporting when required.
Selection Criteria:
* Postgraduate qualifications (or progress towards) with considerable relevant work experience in clinical trial coordination, implementation and management; or, an equivalent combination of relevant experience and/or education/training.
* Demonstrated ability to operate effectively as a member of, and manage, a small team of project staff.
* Demonstrated decision making skills and the ability to solve problems discretely by using innovation and exercising diagnostic skills within areas of functional responsibility or professional expertise.
* Demonstrated effectiveness in both oral and written communication with the ability to consult and liaise effectively with a diverse range of people and a wide variety of people with cross-cultural sensitivity.
* Demonstrated high levels of computer literacy in the full MS Office Suite of products including databases, word processing, spreadsheets, survey software online diary management, conferencing, and encrypted data management software.
* Demonstrated sharp attention to detail and evidence of ability to adhere strictly to protocol, working guidelines with outstanding record keeping.
* Demonstrated experience in budget management and forecasting for staffing and resources.
Desirable:
* Clinical expertise in an area aligned with maternity care or relevant allied health discipline.
* Experience with building and using REDCap databases.
* Experience in managing ethics and governance submissions using the WA Health RGS portal.
* Extensive experience in the establishment, implementation, conduct, management and completion of clinical trials at Project Manager level.
About Curtin University
We are an energetic, dedicated team of academics and professionals working together to provide global solutions through quality graduates and innovative research. Curtin is a welcoming space where integrity, respect for one another, courage, excellence, and impact are essential to everyday life. First Nations people, those identifying as LGBTQIA+, parents, carers, people of all ages, abilities and genders, and people of diverse ethnicity, nationality and faith are encouraged to apply.