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Clinical Trial Manager I/Ii ( Melbourne Only)

2+ years
Not Disclosed
10 April 30, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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