Clinical Trial Manager – FSP

This is a fully remote position, open to applicants in Australia.

📋 Description

• Deliver the final clinical outcome within the agreed contractual timeframe.

• Oversee the operational and quality facets of assigned low- to moderate-complexity studies in adherence to ICH GCP standards.

• Take on the role of Clinical Study Manager for smaller or less complex projects as necessary.

• Create clinical tools such as Monitoring Plans and Monitoring Guidelines, along with the Data Quality Plan.

• Contribute to the Master Action Plan and ensure the relevant sections of the Trial Master File are maintained.

• Engage in the development of CRFs, CRF guidelines, informed consent templates, and protocol-specific documents.

• Prepare, arrange, and conduct client meetings alongside the project manager.

• Collaborate with clinical teams and other departments to achieve project goals.

• Lead team meetings to communicate timelines, resources, interactions, and quality expectations.

• Implement and provide training on standardized clinical monitoring procedures.

• Ensure timely archiving of documents and study materials.

• Track clinical activity timelines and metrics, offer project status updates, initiate recovery actions, review monitoring visit reports, and manage CRF collection and query resolution.

• Continuously oversee or co-monitor clinical trials and evaluate performance against contractual commitments.

• Conduct Accompanied Field Visits and manage project finances in smaller regions when necessary.

• Liaise with study sites regarding protocols, patient participation, case report forms, and study-related issues.

• Organize study start-up activities and manage submissions to ethics committees and regulatory bodies.

• Ensure the quality of essential documents meets Regulatory Compliance Review standards.

• Review and address questions from ethics committees.

• Provide insights into clinical activity forecasts.

• Manage clinical resources, delegate tasks, and identify additional resource needs.

⛳️ Requirements

• Bachelor's degree or equivalent and relevant formal academic or vocational qualifications.

• A minimum of 5 years of relevant experience.

• Experience in oncology is considered a plus.

• Familiarity with study start-up processes in Australia is advantageous.

• Proven ability to manage multiple studies and prioritize competing demands simultaneously.

• Strong understanding of study start-up in Australia, including regulatory submissions and investigator site contracts and budgets.

• Demonstrated leadership, mentoring, training, and team integration skills.

• Excellent planning, organizational, prioritization, interpersonal, and problem-solving abilities.

• Knowledge of clinical monitoring practices, processes, and requirements.

• Strong oral and written communication skills.

• Proficiency in the English language.

• Financial literacy and knowledge of budgeting, forecasting, and financial management.

• Understanding of relevant regulations, including ICH/GCP and FDA guidelines.

• Proficient in computer applications including Outlook, Excel, Word, and other computerized tools.

• Ability to adapt in dynamic environments with complex or ambiguous situations.

• Capacity to assess workload against project budgets and adjust resources accordingly.

• Willingness to travel frequently, both domestically and internationally, and drive to site locations.

🏝️ Benefits

• Comprehensive health and wellbeing benefits.

• Wellness programs.

• Employee Assistance Program offering confidential support.

• Flexible work arrangements.

• Generous leave policies.

• Option to purchase additional leave.

• Paid birthday leave.

• Company-paid parental leave.

• Paid volunteer time.

• Access to Thermo Fisher Scientific University Plus online courses.

• LinkedIn Learning.

• Workshops.

• Mentorship programs.