Clinical Trial Manager

Boston Scientific; Sydney; On-site; AUD 150,000 - 210,000; Full time

Benefits offered by this job

Great Place To Work Certified 2024/202

Best Workplaces for Women 2024/2025

Inclusive Employee Resource Groups

2 wellbeing days per year

Discounted health insurance

Annual leave purchase option

Employee Stock Purchase Plan

Employee Assistance Program

Job summary

Boston Scientific in Sydney is seeking a Clinical Trial Manager to lead worldwide trials and programs in Rhythm Management. You'll drive study design, timelines, budgets, and cross-functional teams, collaborating with regulatory affairs and external partners.

The role focuses on data quality, patient safety, and compliant trial execution, with regular travel across NSW, QLD, and VIC. A scientific/clinical background and trial leadership are essential.

Qualifications

• Bachelor’s degree in a relevant scientific, clinical, engineering or healthcare discipline (advantageous).
• Demonstrated experience in clinical research and clinical trial management, ability to lead through lifecycle.
• Experience leading investigational device trials is highly regarded, esp. electrophysiology or cardiology.

Responsibilities

• Writes study protocols, amendments, informed consents and timelines, evaluating literature and data.
• Leads development of clinical strategy and trial design with cross-functional teams.
• Provides clinical input for new product development and post-market surveillance.
• Interacts with regulatory agencies to provide directives and ensure compliance.
• Facilitates communication across Sales, R&D, Regulatory Affairs, Training, and senior management.
• Manages study timelines, budgets and resources; oversees vendors and contracts.
• Supports regulatory submissions and communications with Regulatory Affairs.
• Presents data at industry and regulatory meetings; authors abstracts/publications.
• Writes progress reports for regulatory submissions and ethics committees.
• Identifies and mitigates study risks to protect quality and timelines.
• Ensures studies comply with GCP and internal procedures with focus on data quality and patient safety.
• Provides governance across cross-functional teams and escalation pathways.

Skills

Clinical trials

Regulatory

Vendor management

Cross-functional

Travel readiness

Education

Bachelor's degree

Job description

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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.

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

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