Boston Scientific Clinical Trial Manager - Brisbane 

Australia, Queensland, Brisbane City 

494599203

Luciano Pietro Armando Sallusti
Aislinn Roche

WHAT WILL YOU BE RESPONSIBLE FOR?

• Writes study protocols, protocol amendments, informed consents, clinical study project timelines and scientific papers for publication by evaluating scientific literature and publications, analyzing scientific data and staying abreast of current clinical practice. Efforts and leadership support product approval, indication expansion and claim support, and mandated post market requirements.
• Leads the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction. Provides project leadership and scientific expertise throughout the development and implementation of local or global clinical studies. May lead studies executed by a CRO.
• Provides clinical input for new product development, post market surveillance, recertification and business development. Interacts with various study support groups in order to assist in clinical strategy, the development of study plans, and project deliverables.
• Interacts with regulatory agencies as needed and will use their scientific knowledge in order to provide directives to staff as well as study sites.
• Facilitates communication between Sales and Marketing, R&D, Regulatory Affairs, Training, Senior Management, Key Opinion Leaders/investigators and investigational sites by conducting team meetings, drafting and sending routine correspondence (e.g., newsletters) and by presenting regular updates to senior staff (BPT/PIB, etc.).
• May manage clinical study timelines, budget by utilizing the appropriate project management tools, selecting providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines.
• Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
• Presents scientific data by communicating accurate, succinct summaries of clinical study work at industry gatherings, investigational meetings and regulatory agency meetings. May author scientific abstracts and/or publications.
• Provides accurate progress reports on clinical projects by writing assigned clinical portions of reports for submission to regulatory agencies, Institutional Review Boards, Medical Ethics Committees, etc.

KEY COMPETENCIES REQUIRED FOR SUCCESS

Acts as a resource and mentor for colleagues with less experience
May lead projects with manageable risks and resource requirements, often broader, cross-functional projects

Stays up to date in area of expertise and demonstrates use of that knowledge to successfully achieve goals and objectives.

Pursues all assignments and projects until completion. Follows through on assignments to ensure successful completion.

SKILLS AND QUALIFICATIONS

• Bachelor’s degree
• 7+ years of related work experience or an equivalent combination of education and work experience
• 3+ years of experience managing clinical trials
• Experience leading clinical trials with investigational devices desired, specifically in the field of electrophysiology or cardiology. Atrial fibrillation/flutter ablation knowledge is strongly preferred.
• Strong preference for a professional with a wide range of experience and expertise in a specialized technical field
• Ability to apply comprehensive technical knowledge of a electrophysiology to resolve complex issues in creative ways
• Ability to use in-depth knowledge of business unit functions and cross-functional group dependencies/relationships
• Experience working with and managing external vendors
• Ability to travel across Australia and New Zealand and other countries worldwide