_{13th April, 2026}

Clinical Operations Manager (COM) Australia | Hybrid from Melbourne, Sydney or Brisbane   

Great opportunity to join our high performing team in our growing CRO business. Excellent long term career progression in a supportive company.
  
Who are we?
We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry, you’ll know that we are experts in our field and have an exceptional reputation for supporting our people.
  

Why should you join Avance Clinical?
We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team & support. We’ve doubled in size in the last 3 years and have promoted over 23% of our people in the last 12 months.
  
  
Broad Purpose
  
The Clinical Operations Manager (COM) is responsible for the leadership and management of a team of clinical operations staff (between 10 & 14) comprising Clinical Research Associates (CRAs) and/or Clinical Trial Assistants (CTAs) to ensure delivery of high-quality clinical monitoring services, and for contributing to the training and development of the Clinical Operations team.
  
  
  
Core Responsibilities include
  

• Provide guidance on practical aspects of clinical monitoring, ICH GCP, risk management, issue escalation, time management and general role processes.
• Communicate with internal cross-functional teams and external stakeholders to support clinical operations' deliverables, and to manage expectations and issues.
• Oversight of Clinical monitoring budgets to ensure accurate and feasible delivery of clinical services.
• Actively manage the performance of line reports and individual career development strategies.
• Implement and support staff retention initiatives, drive staff recruitment (including interviews and probation period management) and manage staff severance.
• Manage CRA/CTA resource assignments across the department in conjunction with the COM team, proactively projecting CRA/CTA resource need.
• Conduct accompanied site visits for all CRA line reports on an on-going basis to adhere to the Avance Training Curriculum and Quality Monitoring Policy.
• Perform all activities associated with onsite or remote Pre-Study Visits (PSV), Study Initiation Visits (SIV), Dose Witness Visits (DWV), Interim Monitoring Visits (IMV) and Close-out Visits (COV) and prepare reports to meet both internal and sponsor-driven requirements.
• Develop and manage professional working relationships with key Phase I and Phase II capable sites to enhance the operational excellence between Avance Clinical’s Clinical Operations and Data Operations groups and the site and proactively manage escalations.
• Monitor line reports’ compliance with use of expected company systems and processes; training completion and timecard entry, leave entitlement administration; and expense processing.
• Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, and respond to audit observations, as required.
• Ensure Serious Adverse Events are reported (initial and follow-up) as per protocol requirements.
• Provide practical hands-on monitoring guidance, coaching and mentoring to less experienced clinical operations staff members, and participate in training initiatives.
• Other duties as directed by Line Management or delegate in line with skills, experience and/or qualifications

  
  
  
Departmental Responsibilities
  

• Foster the on-going commitment to maintaining a healthy team culture and promoting good morale, by organising, running and/or actively participating in regular Clinical Operations Team meetings.
• Maintain effective communication with other members of the department.
• Proactively identify risks related to departmental service provision and assist in their mitigation and resolution.
• Manage and track business related expenses as per company policy.
• Identify training needs of the Clinical Operations Team, provide recommendations for, develop and deliver appropriate training actions and programs.
• Contribute to the development of departmental Standard Operating Procedures (SOPs) as required.
• Participate in internal Quality Assurance activities as required, including responding to internal audit findings.

  
  
  
Qualifications, Skills, and Experience
  

• Bachelor’s level degree in life sciences, pharmacy, nursing or appropriate industry experience.
• Industry experience in appropriate positions that complement the requirements of this position (a minimum of 10 years’ experience in the biotech/pharma/CRO industry working in an ICH GCP environment, with a minimum of 5 years on-site monitoring experience).
• Formal ICH GCP training and a working knowledge of ICH GCP Guidelines and other applicable regulatory requirements.
• Clear understanding of the requirement to adhere strictly to client confidentiality
• Possess excellent interpersonal and communication skills, including the ability to keep clients, senior management and other stakeholders informed of project updates and other pertinent information
• Demonstrated ability to take initiative in problem solving and in exercising good judgment.
• Awareness of Privacy Legislation as it applies to the Clinical Trial environment
• Ability to work under pressure in a multi-disciplinary team environment.
• Can build and maintain positive relationships with management, peers, and subordinates.
• Ability to work independently or in a team environment as needed
• Display strong analytical and problem-solving skills
• Ability to travel. Moderate level of interstate travel may be required (up to 50%).

  
  
What next?
As a growing business we’re looking for likeminded people to join us – we hope that’s you.

• To join our team please submit your CV & cover letter as one Microsoft Word document
• You must have full Australian working rights to be considered

  
  
  
  
  
At Avance difference is encouraged, its celebrated and it's something we strive for. We empower cultural, disability, LGBTI+, and gender equality.
  
  
  
  
  
Clinical Trials / Clinical Operations / CRA Manager / Life Science / Sydney / Brisbane / Melbourne / CRA Manager 
  
  
 

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