Clinical Trial Manager – Onco

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

📋 Description

• Lead the management of clinical study site activities by coordinating Clinical staff within a designated geographic area.

• Ensure that site qualification, initiation, interim monitoring, site management, and study close-out activities adhere to study protocols, study plans, and Worldwide SOPs.

• Guarantee the quality and timeliness of clinical deliverables for assigned programs and/or regions.

• Collaborate with Project Management to establish site management targets and monitoring strategies.

• Provide leadership and guidance to clinical site management team members from the start of the study until closure.

• Act as the primary Site Management contact for clinical monitoring and site activities.

• Manage monitoring deliverables in accordance with the study budget and identify any out-of-scope activities.

• Tailor and oversee study-specific Site Management Quality Management Documents, including Clinical Monitoring Plans.

• Ensure compliance with Clinical Monitoring Plans, conduct site visits, prepare trip reports, and follow up on visit letters.

• Review protocol deviations and address visit action items.

• Train CRAs on the clinical aspects of studies.

• Develop and implement strategies for patient recruitment and track enrollment progress.

• Enhance site data quality and address identified needs with actionable plans.

• Monitor and analyze Site Management deliverables, study metrics, financial performance, resource allocation, and trends.

• Oversee compliance of the Trial Management File and ensure inspection readiness.

• Formulate regional monitoring strategies and forecast site visits and staffing requirements.

• Review and finalize trip reports.

• Conduct site qualification, initiation, interim monitoring, and close-out visits as needed.

• Address problems and escalate monitoring and site issues with proposed solutions.

• Identify and mitigate potential risks.

• Represent Site Management as the primary project contact when necessary.

• Conduct co-visits to ensure the quality of site, CRA, and study procedures.

• Perform other assigned duties.

⛳️ Requirements

• Exceptional interpersonal, oral, and written communication skills in English.

• Strong planning, organizational, and time management abilities.

• Excellent presentation skills.

• Ability to adapt to change.

• Capability to manage multiple and diverse tasks with enthusiasm.

• Proficient in negotiation and influencing with diplomacy.

• Initiative and problem-solving capabilities.

• Skill to prioritize tasks, plan proactively, and achieve goals with minimal supervision.

• Ability to lead and motivate a remote team.

• Capacity to provide expertise and input into monitoring and site management process initiatives.

• Strong customer focus and professional interaction with sponsors.

• Extensive knowledge of clinical research principles and processes.

• In-depth understanding of FDA and/or EU Directive regulations, ICH Guidelines, and local regulatory requirements.

• Experience in the relevant therapeutic indication/area of study.

• Thorough understanding of standard operating procedures.

• Proficient in Microsoft Office, eCRF, and IVRS software.

• Skilled in IxRS, CTMS, and EDC systems.

• A four-year college degree or equivalent in biological, physical, or health studies with a minimum of three years as a Senior Clinical Research Associate (or equivalent), OR a two-year college degree or equivalent education/training with at least five years as a Senior Clinical Research Associate, OR a minimum of six months working as CTM/LCRA (or equivalent), supporting a main CTM and coordinating clinical operations activities.

• Travel is required.

• A valid current passport is necessary.

• A driving license is required.

🏝️ Benefits

• A collaborative and inclusive work environment.

• Opportunities for career growth.

• Access to learning and development resources.

• An opportunity to contribute to impactful clinical research.

• Remote work arrangement.