Key skills
Communication
About this role
Role Overview
- Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work
- 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 (clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials)
- Identify and develop training needs for CRAs and third-party vendors
- Generate potential site list from key stakeholders and drive site feasibility process
- Develop and finalize the country recruitment/retention strategy
- Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs
- Support in planning and conducting investigator meetings
- Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees
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)
Benefits
- Excellent communication and interpersonal skills to effectively interface with others in a team setting
- Excellent organizational skills, attention to detail, and a customer service demeanor
- Ability to travel domestically and internationally including overnight stays