Senior Clinical Trial Manager – Tagalog Proficient

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

📋 Description

• Accountable for overseeing site management, clinical monitoring, and central monitoring deliverables, emphasizing patient safety, adherence to protocols/GCP/regulatory standards, and data integrity.

• Manages site interactions from activation through to closeout.

• May be tasked with identifying critical data and processes, as well as risks related to protocol execution, along with implementing risk mitigations in accordance with the Risk Assessment and Categorization Tool (RACT).

• Reviews the study's scope of work, budget, and protocol content, ensuring the clinical project team (CRAs/Central Monitors) is informed of contractual obligations and parameters.

• Utilizes previous clinical experience, operational data, metrics, and reports to pinpoint risks associated with clinical trial management deliverables.

• Alerts the project manager to any risks concerning clinical trial management deliverables (including timeline, quality, and budget) and any activities that fall outside the contracted scope.

• Applies strategic thinking and problem-solving abilities to suggest and implement risk mitigations.

• Engages and presents in key meetings, such as the Kick-Off Meeting.

• Acts as a point of escalation for communications with investigator site personnel and may need to interact via phone or in person with principal investigators or other site staff.

• Collaborates with other functional leaders, such as Study Start-Up, Patient Recruitment, and Data Management, to ensure smooth delivery transitions and achieve study milestones, including site activation targets, enrollment goals, and database lock timelines.

• Reviews and provides input on other functional plans (e.g., Data Management Plan, Communication Plan) relevant to clinical trial management activities.

• Responsible for creating and maintaining clinical study tools and templates, such as the Clinical Monitoring Plan.

• Ensures that CTMS, dashboards, and other systems are established and accessible for the clinical team, including overseeing user acceptance testing (UAT) as necessary.

• Conducts access and audit trail reviews as mandated.

• Coordinates initial and ongoing training for the study team concerning protocol specifics, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans, and timelines for the study.

• Oversees resource allocations for CRAs and Central Monitors, site assignments, and the conduct of study team members, identifying risks to delivery or quality.

• Ensures the quality of clinical monitoring, central monitoring, and site management deliverables within a project, maintaining visibility of its progress through approved systems and/or tracking tools.

• Reviews project oversight dashboards and other clinical trial systems (e.g., Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards) to supervise site and patient activities, study team conduct, and to verify that data is updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) as per the plan.

• Understands the necessary monitoring strategy for the study and, when required, contributes to the development of the study risk assessment plan.

• Is accountable for ensuring that assigned clinical team members understand, comply with, and deliver according to the specified monitoring strategy, CMP/SMP, and risk plans.

• Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports, and pertinent correspondence) to confirm they accurately reflect site management activities and convey any risks to protocol/GCP compliance, trial conduct, patient safety, or data integrity.

• Documents requested revisions and approvals in CTMS.

• Ensures that these deliverables are submitted in line with company and/or sponsor specifications, including delivery deadlines.

• Engages with the client and other functional departments concerning clinical monitoring, central monitoring, and site management activities and deliverables.

• Provides status updates on clinical deliverables and risks to clients, project management, and leadership in accordance with departmental or study agreements.

• Proposes solutions for obstacles in protocol execution and site management.

• Demonstrates an understanding of the roles of other functions in achieving compliance and delivery according to protocol, SOPs, ICH GCP, and country regulations.

• Supports Inspection Readiness within the clinical trial management scope.

• Oversees CRAs and Central Monitors assigned to the study and routinely evaluates study-specific process and training compliance, CMP compliance, while identifying emerging risks.

• May develop and assist in the execution of corrective action plans at both site and study levels.

• Supports and completes activities aimed at meeting data cut and lock deadlines.

• Provides feedback to line managers regarding staff performance, highlighting both strengths and areas for improvement.

• May be assigned to larger, more complex trials.

⛳️ Requirements

• Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.

• Proven ability to lead and align teams in achieving project milestones.

• Demonstrated capability to work in an international environment.

• Proven expertise in site management and monitoring (either clinical or central).

• Experience with risk-based monitoring is preferred.

• Demonstrates understanding of clinical trial management financial principles and budget oversight.

• Knowledge of Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Must display proficient computer skills.

• Excellent communication, presentation, and interpersonal skills with project teams and site personnel.

• Strong conflict resolution abilities.

• Proven ability to apply problem-solving techniques to address complex issues and utilize a risk management approach to identify and mitigate potential threats to the successful execution of a clinical research project.

• Demonstrates critical thinking to ascertain the cause and appropriate solutions for identified issues.

• Moderate travel may be necessary, estimated at around 20%.

🏝️ Benefits

• Health insurance

• Competitive salary

• Professional development opportunities