Clinical Trial Manager

Job description

**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 in area of expertise and demonstrates use of that knowledge to successfully achieve goals and objectives. **Global Perspective** Understands the position of the organization within a global context and adopts and helps others to adopt a global approach. Leverages solutions that are scalable, efficient, and cost effective. Encourages others to share knowledge to ensure success of team, business unit, and organization. **Collaboration** Works effectively with others across the team to achieve goals. Demonstrates proficient communication and partnership in interactions with others. **Relationship Building** Establishes and maintains strong relationships internally and externally. Contributes to a culture of respect, diversity, and inclusion. Earns the respect and trust of others through effective interpersonal skills, integrity and authenticity. **Customer Focus** Identifies internal / external customer needs and ensures the effective delivery of high-quality solutions, products and services that meet or exceed customer expectations. **Communication** Creates an environment which promotes the free flow of communication and information throughout the team. Communicates effectively in large and small groups. Openly shares knowledge and expertise. Listens actively and encourages the open expression of ideas and opinions. **Planning & Execution** Implements initiatives and plans that align with individual and team objectives. Carries out initiatives with clear deliverables, milestones, accountabilities and measures of success. Pursues all assignments and projects until completion. Follows through on assignments to ensure successful completion. SKILLS AND QUALIFICATIONS - Bachelor’s degree in a relevant scientific, clinical, engineering or healthcare discipline; an advanced degree is advantageous - Demonstrated experience in clinical research and clinical trial management, with the ability to lead studies through key stages of the clinical trial lifecycle. - Experience leading investigational device clinical trials is highly regarded, particularly within electrophysiology or cardiology. - Knowledge of atrial fibrillation/flutter and ablation therapies would be a strong advantage. - Strong technical expertise with the ability to apply your knowledge to complex clinical, study and business challenges. - The ability to interpret complex information, solve problems pragmatically and bring a creative, solutions-focused approach. - Comfortable working across functions and building strong relationships to influence decisions and deliver outcomes in a matrixed environment. - Experience partnering with and managing external vendors and clinical research partners. - Flexibility to travel across Australia and New Zealand, with international travel as required. WHY CHOOSE US? - Great Place To Work Certified in 2024 & 2025 - Best Workplaces for Women in 2024 & 2025 - Inclusive Employee Resource Groups - 2 Wellbeing Days per year - Discounted health insurance - Ability to purchase additional Annual Leave - Employee Stock Purchase Plan - Access to Employee Assistance Program **Requisition ID:**636416