General Manager Medical Device jobs

The Senior Clinical Operations Manager will play a critical role in the successful execution of Synchron’s clinical trial activities in Australia. This role is responsible for end-to-end program management of assigned clinical studies, with a primary focus on operational execution, site readiness, patient enrollment, and high-quality study delivery for Synchron’s implantable BCI system.

Key responsibilities include managing all phases of trial operations, from start-up through closeout, for moderate- to high-complexity and/or multi-center studies. The role proactively resolves site and vendor issues, manages study timelines, budgets, and resourcing, and ensures compliance with internal SOPs, ICH/GCP, ISO 14155, and applicable Australian regulatory and ethics requirements. In addition, this role supports local operational readiness for Synchron’s Australia trial activities, coordinating essential field logistics and office-based operational needs.

Reporting to the VP of Clinical, this position is essential to maintaining operational excellence and ensuring trials meet both regulatory and business objectives in Australia. The ideal candidate will bring significant experience managing clinical trials for Class III medical devices.

• Serve as the primary clinical program lead for Synchron’s Australia-based clinical trial(s), owning execution from study start-up through closeout.
• Coordinate site activation activities, including site readiness, training, documentation, and trial initiation.
• Act as the central point of accountability for patient enrollment planning and execution, working closely with investigators, site teams, and internal stakeholders.
• Partner closely with Clinical Science to ensure protocol execution aligns with study objectives and data quality expectations.
• Monitor study progress, identify operational risks, and proactively implement mitigation strategies.
• Ensure trials are conducted in compliance with protocols, ICH/GCP, ISO 14155, local regulations (including TGA/HREC requirements), and internal SOPs.
• Manage and mentor Clinical Operations staff, including CRAs and clinical monitors, ensuring effective training and alignment with organizational goals.
• Support preparation and review of clinical documentation, including study plans, monitoring reports, deviations, and regulatory submissions.
• Facilitate cross-functional communication across Clinical Operations, Regulatory, Field teams, and leadership to maintain alignment and execution focus.
• Support investigator and site relationship management, fostering strong collaboration and accountability.
• Support trial enabling field and local operations in Australia, including coordination of device and equipment logistics(shipping, receiving, inventory tracking, returns), local vendors and services (couriers, supplies), and office readiness, escalating issues that could impact trial timelines or quality.

• Bachelor’s degree in health science, nursing, science, or biomedical engineering.
• Desired Education: Master’s or advanced degree in health science, nursing, science, or biomedical engineering, with relevant experience in BCI or neuromodulation clinical research.
• 5-7years of experience in the medical device industry, with a focus on monitoring and managing clinical trials, including at least 3 years in a leadership role.
• Must be highly motivated, have excellent interpersonal and written communication skills, great desire to help others, composed under stress and well organized
• Identifies and resolves issues in a proactive, creative, and timely fashion.
• Experience with Class III active implantable medical devices.

• Experience working in a dynamic, rapidly evolving startup environment.
• Demonstrated clinical and scientific aptitude.
• Working knowledge of ISO 14155, ICH, FDA guidance/regulations, and other relevant global standards pertaining to clinical research
• Proven ability to prioritize tasks, manage multiple timelines, and meet deadlines in a multi-project framework.
• Strong understanding of how quality, clinical, and regulatory processes intersect, with experience supporting or leading audits.
• Excellent verbal and written communication skills, with the ability to negotiate effectively and build strong relationships.
• Ability to adapt to shifting priorities while maintaining thorough documentation and record-keeping practices.

In addition to base pay, this role may be eligible for discretionary bonuses and/or equity grants subject to board approval and company policy.

Equal Employment Opportunity (EEO)

Synchron is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and provide equal employment opportunities without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other characteristic protected by applicable law.

If you need a reasonable accommodation during the application or interview process, please let us know.

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