Clinical Research Manager II

Location: New South Wales

Employer: Avance Clinical Pty Ltd

Employment Type: Full-time, ongoing

About the Company

Avance Clinical is an Australian Contract Research Organisation (CRO) providing specialised clinical research services to pharmaceutical and biotechnology companies worldwide. We are committed to excellence in clinical trial management, regulatory compliance, and the successful delivery of innovative therapies that improve patient outcomes.

About the Role

We are seeking an experienced Clinical Research Manager II to join our Clinical and Project Operations team. The successful candidate will be responsible for leading the planning, coordination, and execution of clinical trials, ensuring that projects are delivered on time, within budget, and in compliance with ICH GCP, SOPs, and all applicable regulatory requirements.

Key Responsibilities

• Manage all aspects of clinical project delivery from initiation to completion.
• Coordinate internal and external stakeholders including sponsors, vendors, and site staff.
• Oversee project timelines, budgets, and financial performance.
• Review Trial Master File documentation to ensure accuracy and completeness.
• Identify and manage project risks, issues, and deviations.
• Lead communication with sponsors and regulatory bodies.
• Mentor and provide guidance to junior project management staff.
• Contribute to departmental SOP development and quality assurance activities.
• Responsible for planning and executing clinical trials, coordinating study team members and processes to deliver projects on time, within budget, and with desired outcomes.
• Develops study plans, operational documents, and departmental SOPs to support effective execution of clinical and project operations.
• Leads and manages internal teams and external stakeholders including sponsors, vendors, and site staff across all stages of research projects.
• Oversees financial performance of assigned research projects, including revenue recognition, forecasting, contract management, invoicing, and payment tracking.
• Ensures compliance with study protocols, Standard Operating Procedures (SOPs), ICH GCP guidelines, and applicable regulatory requirements.
• Maintains effective communication with sponsors, senior management, and external regulatory bodies to manage timelines, expectations, and risks.
• Participates in and responds to study-specific or vendor audits conducted by sponsors or regulatory agencies.
• Reviews study protocols and documentation, evaluates and controls risks, and ensures accuracy and completeness of research data and trial master files.
• Provides guidance and mentoring to less experienced project management staff, supporting development of departmental knowledge and capability.
• Monitors and evaluates project performance from initiation to completion to ensure delivery of research outcomes and quality objectives.
• Reports progress and findings to senior management and clients, ensuring transparency of research outcomes and compliance status.
• Contributes to the development and implementation of departmental procedures, quality systems, and continuous improvement initiatives.
• Manages and mitigates operational and compliance risks related to research and development projects.
• Demonstrates leadership in applied research management within the pharmaceutical and biotechnology sector.

Skills and Experience

• Bachelor's degree (or higher) in Sciences, Pharmacy, Nursing, or a related discipline. At least five years of relevant experience may substitute for the formal qualification.
• Minimum of 2 years' experience as a Clinical Research Manager within a CRO or pharmaceutical company.
• Prior experience as a Clinical Research Associate (CRA) is highly regarded.
• Strong knowledge of ICH GCP and relevant regulatory frameworks.
• Demonstrated project management, leadership, and stakeholder communication skills.
• Excellent problem-solving abilities and attention to detail.
• Ability to work effectively under pressure in a multidisciplinary team environment.
• Willingness to support a positive and collaborative team culture.

Why Join Avance Clinical

• Be part of a rapidly growing, globally recognised CRO headquartered in Australia.
• Work with leading biotechnology and pharmaceutical partners.
• Supportive and collaborative work environment with opportunities for professional growth.
• Competitive salary package based on experience and qualifications.