Clinical Trial Manager (FSP)

This is a home-based position, preferably based in central Sydney.

About the Role

Join us as a Clinical Trial Manager and make an impact at the forefront of innovation. The Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. You will interpret data on project issues and make sound business decisions with support from experienced team members or your line manager. Your role ensures all clinical deliverables meet the customer's time, quality, and cost expectations while maintaining profitability through efficient management of the clinical team.

Responsibilities

• Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP.
• Assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects, in accordance with project-specific requirements.
• Develop clinical tools (e.g., Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan.
• Contribute to the development of the Master Action Plan (MAP) for providing clinical-related documents.
• Ensure timely set-up, organization, content, and quality of the relevant sections of the Trial Master File (local and central).
• Participate in the design and development of CRFs, CRF guidelines, patient informed consent templates, and other protocol-specific documents as required.
• Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
• Work with the clinical team and other departments to meet project deliverables.
• Regularly communicate with the team and lead team meetings to ensure timelines, resources, interactions, and quality are maintained.
• Implement and train standardized clinical monitoring processes within the study and according to corporate standard policies.
• Ensure timely archiving of documents and study materials for the department.
• Achieve the final clinical deliverable within the contractual time period by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution.
• Continuously monitor or co-monitor clinical trials to assess performance and ensure contractual obligations are met.
• In smaller regions, routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
• Communicate with study sites regarding issues such as protocol, patient participation, case report form completion, and other study-related issues.
• Coordinate all start-up activities and ensure timely ethics committee and regulatory submissions (if appropriate).
• Ensure essential document quality meets the expectation of Regulatory Compliance Review and follow up on all questions raised by ethics committees.
• Provide input into the preparation of forecast estimates for clinical activities.
• Responsible for clinical resource management, assignment, delegation of clinical responsibilities, and identification of additional resource requirements.

Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
• Experience within oncology will be considered advantageous.
• Study start-up experience within Australia will be considered an asset.
• Experience managing multiple studies and competing priorities simultaneously.

Skills

• Strong knowledge of the study start-up process in Australia, including regulatory submissions and the development and negotiation of investigator site contracts and budgets.
• Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams.
• Agile, flexible, and resourceful, with the ability to work efficiently in a fast-paced environment.
• Good planning and organizational skills to enable effective prioritization of workload.
• Solid interpersonal and problem-solving skills to enable working in a multicultural matrix organization.
• Capable of working effectively in a changing environment with complex/ambiguous situations.
• Familiarity with the practices, processes, and requirements of clinical monitoring.
• Good judgment and decision-making skills.
• Effective oral and written communication skills, including English language proficiency.
• Capable of evaluating workload against project budget and adjusting resources accordingly.
• Sound financial acumen and knowledge of budgeting, forecasting, and fiscal management.
• Solid understanding of relevant regulations, e.g., ICH/GCP, FDA guidelines, etc.
• Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.

Environmental Conditions

• Work is performed in an office environment with exposure to electrical office equipment.
• Frequent driving to site locations and frequent domestic and international travel.

Benefits

• Health & Wellbeing: Comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
• Flexibility: Balance your work and personal life with flexible arrangements.
• Extra Leave: Generous leave policies, including the option to purchase additional leave, paid birthday leave, and company-paid parental leave.
• Charitable Giving & Volunteering: Paid volunteer time to support non-profit organizations that matter to you.
• Learning & Development: Access to online courses via Thermo Fisher Scientific University Plus and LinkedIn Learning, workshops, and mentorship programs for continuous learning and skill development.