Global Clinical Trial Manager, Cardiac Rhythm Devices

Nearheal

Sydney

Hybride

AUD 120 000 - 180 000

Plein temps

Il y a 9 jours

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Avantages offerts par ce poste

Great Place ToWork
Women-friendly awards
ERGs
Wellbeing days
Discounted health insurance
Extra Annual Leave
Stock Purchase Plan
Employee Assistance

Résumé du poste

Nearheal is seeking a Clinical Trial Manager in Sydney to lead worldwide studies and cross-functional clinical teams in support of product development and commercialization. The role requires deep regulatory knowledge and hands-on management of trial design, timelines, and budgets.

The successful candidate will travel regularly across NSW, QLD, and VIC, coordinating with regulatory bodies and healthcare partners to advance clinical programs while ensuring patient safety and data integrity.

Qualifications

  • Bachelor’s degree in a relevant scientific, clinical, engineering or healthcare discipline.
  • Demonstrated experience in clinical research and clinical trial management.
  • Experience leading investigational device trials is highly regarded in electrophysiology/cardiology.
  • Knowledge of atrial fibrillation/flutter and ablation therapies is advantageous.
  • Strong ability to interpret complex information and solve problems pragmatically.

Responsabilités

  • Writes study protocols, amendments, informed consents, and study timelines; evaluates literature and data to support approvals and post-market requirements.
  • Leads development of clinical strategy and trial design; may lead CRO-executed studies.
  • Provides clinical input for new product development and post-market surveillance; collaborates across functional study teams.
  • Interacts with regulatory agencies and ensures compliance with GxP and regulatory requirements.
  • Communicates progress and findings to senior staff and stakeholders through reports and presentations.
  • Manages study timelines, budgets, vendors, and contracts to stay within approved budgets.

Connaissances

Clinical trial mgmt
Cross-functional leadership
Regulatory knowledge
Stakeholder engagement
Vendor management
Travel readiness

Formation

Bachelor's degree
Advanced degree advantageous

Description du poste

Nearheal is seeking a Clinical Trial Manager in Sydney to lead worldwide studies and cross-functional clinical teams in support of product development and commercialization. The role requires deep regulatory knowledge and hands-on management of trial design, timelines, and budgets.

The successful candidate will travel regularly across NSW, QLD, and VIC, coordinating with regulatory bodies and healthcare partners to advance clinical programs while ensuring patient safety and data integrity.

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