Senior Clinical Trials Assistant / Sydney

Immediate requirement for an experienced Senior Clinical Trials assistant (SCTA) to work on exciting early phase projects, the role will be at a rapidly growing global biopharmaceutical company  The scope of responsibilities will include:

• Preparation, conduct, and reporting of selection, initiation, routine and closeout monitoring visits
• Site management, general administration of clinical research studies in Australia.
• Contact for clinical investigators, vendors and support services in regard to study progress
• Monitoring trial progress and ensuring that the project timelines are met
• Facilitation of site budgets and contract negotiations
• Effective and open communication within the project team
• Delivering onsite training of investigators and staff
• Preparation and delivering of presentations at Investigator's Meetings
• Preparation for and attendance at company's audits; resolution of audit findings
• Support to global Regulatory Affairs in procurement of site regulatory documents
• Maintenance of appropriate documentation regarding clinical site management
• Participation in feasibility research
• Participation in query resolution
• Maintenance of study-specific automated tracking systems

Qualifications:

University degree preferably in life sciences (Pharma ETC) 

• At least 2-3 years of LOCAL experience at a similar position, with full scope of monitoring responsibilities within Phase I/II Clinical Trials.(Oncology) 
• Clinical trials administration  experience in Australia.
• Fluent English, spoken and written.
• Team oriented with excellent communication and interpersonal skills including a positive and professional attitude to tasks and projects
• Good problem solving abilities, flexibility
• Demonstrated computer skills (MS Office applications)
• Full working rights in Australia