Clinical Trials Operations Specialist

MSD; Sydney; Hybrid; AUD 70,000 - 95,000; Full time

Job summary

MSD in Sydney's Macquarie Park is seeking a Clinical Trials Coordinator (CTC) to support trial and site administration across the clinical lifecycle. You will help deliver site-ready dates, manage documents, budgeting, and regulatory submissions, while coordinating with COM, CRM and CRA colleagues in a flexible, collaborative team.

The role emphasizes strong organisational and communication skills, the ability to manage multiple tasks, and proficiency with Clinical Trial Management Systems and

Qualifications

• Bachelor’s degree or relevant job training in office management, administration, finance or healthcare
• Fluent in local language(s) and business proficient in English
• Strong communication skills, both written and verbal, including with sites and investigators
• Good understanding of Global and Country/Regional Clinical Research Guidelines, ICH‑GCP and Good Documentation Practices
• Strong IT skills, including MS Office, Excel and clinical applications, with the ability to adapt quickly to new systems
• Effective time management, organisation, interpersonal, conflict management and negotiation skills
• High accountability and urgency, with the ability to prioritise and manage multiple tasks in a changing environment
• Ability to work independently and in a matrix, multicultural environment
• Strong customer focus and a proactive, solution‑oriented mindset

Responsibilities

• Trial and Site Administration
• Track essential documents and report safety reports
• Ensure collation and distribution of study tools and documents
• Update Clinical Trial Management Systems and tracking tools
• Support clinical and non-clinical supply management in collaboration with other country roles
• Manage labelling requirements and coordinate/sign translation change requests, where applicable
• Support the CRAs to enter site staff into the training portal to ensure training compliance
• Document Management
• Prepare documents and correspondence
• Collate, distribute/ship and archive clinical documents, including electronic Trial Master File (eTMF)
• Assist with eTMF reconciliation and quality control activities
• Update manuals and documents, such as patient diaries and instructions
• Support proper destruction of clinical supplies
• Prepare Investigator Trial File binders
• Obtain translations of documents
• Regulatory and Site Start‑Up
• Provide to and collect from investigators forms and lists for site evaluation, site start‑up and submissions
• Obtain, track and update study insurance certificates
• Support preparation of submission packages for Ethics / Research Governance Office and Regulatory Agencies (RA)
• Support publication of study results for GCTO and RA, where required by local legislation
• Budgeting, Agreements and Payments
• Develop, control, update and close out country and site budgets, including split site budgets
• Develop, negotiate, approve and maintain contracts, including CTRAs
• Track and report contract negotiations
• Update and maintain contract templates in cooperation with Legal
• Calculate and execute payments to investigators, vendors and grants
• Ensure adherence to financial and compliance procedures
• Monitor and track adherence and disclosures
• Maintain tracking tools and process FCPA documentation in a timely manner
• Meeting Planning and Support
• Organise meetings, including study memos, letters and protocols
• Support local investigator meetings, including invitations, materials, venue management and vendor support as required
• Support project‑related activities as required
• Participate in inclusion initiatives and occupational health and safety activities as required
• Digital Proficiency
• Uses approved clinical systems, document‑management tools, trackers, metrics dashboards and collaboration platforms accurately; maintains data quality in assigned systems; and applies basic automation, analytics and approved AI‑enabled tools with guidance to complete assigned work efficiently, consistently and compliantly

Job description

MSD in Sydney's Macquarie Park is seeking a Clinical Trials Coordinator (CTC) to support trial and site administration across the clinical lifecycle. You will help deliver site-ready dates, manage documents, budgeting, and regulatory submissions, while coordinating with COM, CRM and CRA colleagues in a flexible, collaborative team.

The role emphasizes strong organisational and communication skills, the ability to manage multiple tasks, and proficiency with Clinical Trial Management Systems and