Clinical Trials Coordinator - Flexible, Impactful Role

Merck Sharp & Dohme Corp.; Sydney; Hybrid; AUD 70,000 - 110,000; Full time

Benefits offered by this job

Flexible work arrangements

Benefits

Job summary

Merck Gruppe - MSD Sharp & Dohme in Sydney's Macquarie Park is seeking a Clinical Trials Coordinator to support trial and site administration across the clinical trial lifecycle in a permanent full-time role. You will work with local stakeholders, manage document control, regulatory submissions, budgeting, and payments, while ensuring training compliance and data quality in CTMS.

This position offers flexible working arrangements and a collaborative team environment with opportunities for

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
• 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

• 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
• 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
• 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
• 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
• 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
• 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

Merck Gruppe - MSD Sharp & Dohme in Sydney's Macquarie Park is seeking a Clinical Trials Coordinator to support trial and site administration across the clinical trial lifecycle in a permanent full-time role. You will work with local stakeholders, manage document control, regulatory submissions, budgeting, and payments, while ensuring training compliance and data quality in CTMS.

This position offers flexible working arrangements and a collaborative team environment with opportunities for