Clinical Trial Manager – Onco

Worldwide Clinical Trials

. Lead delivery of clinical study site management activities through coordination of Clinical staff within a geographic region .

Posted 10/28/2026full-timeRemote • AustraliaJuniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive understanding of clinical research principles, FDA and EU regulations, and ICH Guidelines while effectively leading and managing clinical site activities. Proficient in developing patient recruitment strategies and ensuring compliance with study protocols and quality management documents.

Highest-signal resume keywords

Clinical Research PrinciplesFDA RegulationsSite ManagementPatient Recruitment StrategiesMonitoring Strategy

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Clinical Monitoring PlansSite QualificationInterim MonitoringStudy Close-OutData Quality ImprovementResource AllocationProtocol Deviations ReviewFinancial Performance TrackingRisk IdentificationStudy Metrics Analysis

Soft Skills

Interpersonal CommunicationOrganizational SkillsProblem-Solving SkillsTeam LeadershipNegotiation Skills

Tools & Technologies

Microsoft OfficeECRFIVRS PackagesIxRSCTMSEDC Systems

Industry Keywords

Clinical Study ManagementSOP ComplianceStudy Therapeutic IndicationInspection ReadinessClinical Operations

About the role

Key responsibilities & impact

Lead delivery of clinical study site management activities through coordination of Clinical staff within a geographic region
Ensure site qualification, initiation, interim monitoring, site management, and study close-out activities comply with study protocols, study plans, and Worldwide SOPs
Ensure quality and timeliness of clinical deliverables for assigned programs and/or regions
Collaborate with Project Management to set site management targets and monitoring strategy
Provide leadership and direction to clinical site management team members from study start through closure
Serve as the primary Site Management contact for clinical monitoring and site activities
Manage monitoring deliverables against study budget and identify out-of-scope activities
Customize and oversee study-specific Site Management Quality Management Documents, including Clinical Monitoring Plans
Oversee compliance with Clinical Monitoring Plans, site visits, trip reports, and visit follow-up letters
Review protocol deviations and visit action items
Train CRAs on clinical aspects of studies
Develop and implement patient recruitment strategies and track enrollment
Improve site data quality and address identified needs with action plans
Track and analyze Site Management deliverables, study metrics, financial performance, resource allocation, and trends
Oversee Trial Management File compliance and inspection readiness
Formulate regional monitoring strategy and forecast site visits and staffing needs
Review and finalize trip reports
Perform site qualification, initiation, interim monitoring, and close-out visits as needed
Solve problems and escalate monitoring and site issues with proposed solutions
Identify and mitigate risks
Represent Site Management as primary project contact when required
Conduct co-visits to ensure site, CRA, and study procedure quality
Perform other assigned duties

Requirements

What you’ll need

Excellent interpersonal, oral and written communication skills in English
Excellent planning, organizational, and time management skills
Excellent presentation skills
Flexibility to change
Ability to manage multiple and varied tasks with enthusiasm
Ability to negotiate and influence with diplomacy
Initiative and problem-solving skills
Ability to prioritize tasks, plan proactively, and accomplish goals with minimal supervision
Ability to lead and motivate a team remotely
Ability to provide experience and input into monitoring and site management process initiatives
Strong customer focus and professional interaction with sponsors
Extensive understanding of clinical research principles and processes
Strong understanding of FDA and/or EU Directive regulations, ICH Guidelines, and local regulatory requirements
Experience in the study therapeutic indication/area
Thorough understanding of standard operating procedures
Proficient knowledge of Microsoft Office, eCRF, and IVRS packages
Proficiency with IxRS, CTMS, and EDC systems
Four-year college curriculum or equivalent with a major concentration in biological, physical, or health studies and a minimum of three years as a Senior Clinical Research Associate (or equivalent), OR two-year college curriculum or equivalent education/training and a minimum of five years as a Senior Clinical Research Associate, OR minimum six months functioning as CTM/LCRA (or equivalent), supporting a main CTM and coordinating clinical operations activities
Travel required
Valid current passport required
Driving license required

Benefits

Comp & perks

Collaborative and inclusive work environment
Career growth opportunities
Learning and development opportunities
Opportunity to contribute to life-changing clinical research
Remote work arrangement