Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies
Primary clinical point of contact with the client
Collaborate with PM on monthly invoicing and variance management of clinical budget
Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals)
Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices
Generate potential site list from key stakeholders and drive site feasibility process
Develop and finalize the country recruitment/retention strategy
Ensure effective and timely feasibility, site start-up, enrollment, maintenance and close-out procedures
Lead internal clinical team meetings and set expectations for the clinical team
Requirements
Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred
Minimum of 5-8 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience. Oncology (Phase I) trial experience in Australia preferred
Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
Excellent organizational skills, attention to detail, and a customer service demeanor
Ability to travel domestically and internationally including overnight stays