Clinical Study Manager

2 days ago

Sydney, New South Wales, Australia beBeeResearch Full time $90,000 - $120,000
Job Overview

The role of a Clinical Research Associate involves working directly with sponsors to conduct monitoring activities across various trials in a remote or on-site hybrid setting.

Key Responsibilities:

  • Ensure compliance with ICH-GCP and local regulations by maintaining accurate documentation and procedural records.
  • Monitor and manage study sites, collaborating with project managers to facilitate patient recruitment and progress updates.
  • Train and support investigators and site staff, contributing to team meetings and performance improvement initiatives.
  • Identify and escalate study-related issues, driving performance at sites and ensuring timely resolution.
  • Manage data entry, source verification, and query resolution to maintain high-quality study data.
  • Coordinate study supplies, drug accountability, and pharmacovigilance activities to ensure regulatory compliance.
  • Collaborate with cross-functional departments to prepare for audits and inspections, providing accurate monitoring visit reports within set timelines.
  • Contribute to the quality of study data through collaboration with data management teams.
  • Maintain compliance with company SOPs, work processes, and policies.

Requirements:

  • University degree in life sciences or a related field.
  • Full driving license and ability to travel nationally as required.
  • Minimum 18 months of independent monitoring experience.
  • Strong knowledge of international guidelines (ICH/GCP) and basic understanding of GMP/GDP.
  • Pharmaceutical industry experience, preferably in a sponsor or CRO environment.
  • Full Australian working rights.

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