Clinical Trial Manager

Hiring Manager: Luciano Pietro Armando Sallusti Recruiter: Aislinn Roche ABOUT THE ROLE   Combining the most advanced and least-invasive rhythm management technologies available with an unwavering commitment to deep collaboration with healthcare professionals, we’re helping to reduce costs, improve outcomes and enhance patients’ lives.  The Clinical Trial Manager is responsible for the design, planning, execution and leadership of clinical studies and clinical programs worldwide as well as leading cross functional clinical teams in support of the organization's business objectives for product development and/or commercialization. Possesses a technical knowledge of products, processes, and regulatory requirements for clinical trials conducted within the Rhythm Management therapeutic area.   This role is based in Sydney and reports to the Clinical Trial Manager, EMEA. This role will require regular travel across NSW, QLD and VIC.   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.).

Manages clinical study timelines, budgets and resources; selects and oversees providers, manages vendor contracts and performance, and ensures expenditures remain within approved 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.

Proactively identifies, assesses, escalates and mitigates study risks, issues and dependencies, driving timely cross-functional decisions and corrective actions to protect study quality, timelines and objectives. Ensures clinical studies are conducted in compliance with applicable regulations, Good Clinical Practice, internal procedures and study-specific requirements, with appropriate focus on data quality, patient safety and inspection readiness. Provides clear governance and accountability across cross-functional study teams, aligning stakeholders on priorities, decisions, deliverables and escalation pathways across countries and functions.

KEY COMPETENCIES REQUIRED FOR SUCCESS   Functional Expertise Stays up to date