Job Title: Clinical Trial Manager I/II
Company: Syneos Health
Location: Melbourne, Australia (Only)
Job ID: 25003435
Updated: Today
About Syneos Health:
Syneos Health® is a fully integrated biopharmaceutical solutions organization driven to accelerate customer success. With 29,000 employees across 110 countries, Syneos Health translates clinical, medical affairs, and commercial insights into tangible outcomes to meet modern healthcare challenges.
Why Join Us:
Career growth and development support
Total rewards program with peer recognition
Inclusive “Total Self” culture promoting authenticity and belonging
Work that truly matters – every role contributes to changing lives
Job Responsibilities:
Oversee site management, clinical monitoring, and central monitoring deliverables, focusing on patient safety, protocol compliance, and data integrity.
Manage site activities from activation through closeout, including recruitment and investigator payments.
Evaluate risks using tools like RACT and propose/implement mitigations.
Ensure awareness of study scope, budget, and protocols among CRAs and central monitors.
Escalate issues impacting timeline, quality, or scope to Project Manager.
Lead or participate in Kick-Off Meetings and serve as escalation point for site communication.
Collaborate with cross-functional teams (Start-Up, Recruitment, Data Management) to meet milestones.
Develop, maintain, and oversee clinical tools, templates, and monitoring plans.
Ensure proper setup and usage of CTMS, dashboards, and trial systems.
Train study teams on protocol specifics, CRF completion, SOPs, timelines, and monitoring strategy.
Manage CRA and Central Monitor resourcing and conduct quality assessments.
Conduct oversight of monitoring reports, visit documentation, and site correspondence.
Provide clinical status updates and risk reporting to internal and external stakeholders.
Support inspection readiness and ensure compliance with ICH GCP, SOPs, and local regulations.
Identify risks at the site/study level and ensure appropriate action plans are implemented.
Provide feedback on team performance and oversee complex trial execution.
Qualifications:
Bachelor’s degree in life sciences or RN equivalent
Proven leadership in aligning teams to meet project goals
Experience in international trials and site monitoring (clinical/central)
Knowledge of risk-based monitoring and financial principles in clinical trial management
Understanding of GCP, ICH, and regulatory requirements
Strong interpersonal, presentation, and conflict resolution skills
Proficient in computer applications and clinical trial systems
Ability to solve complex issues using critical thinking and risk management
Willingness to travel up to 20%
Additional Information:
Role scope may evolve at the discretion of the company
Equivalent education or experience may be considered
Commitment to equality, diversity, and compliance with regional legislation
Reasonable accommodations available under ADA guidelines
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