Clinical Regional Project Lead

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

📋 Description

• Manage, oversee, and coordinate the activities of project teams across designated countries.

• Ensure the uniformity of Clinical Operations processes across different regions.

• Guarantee that study milestones are achieved by the project team at both country and regional levels.

• Plan, implement, and manage projects in adherence to industry regulations, ICH-GCP, essential study documents, and relevant controlled documents.

• Serve as the primary or secondary project management contact for project teams and PSI support services in the specified countries.

• Conduct study status reviews and progress reporting when assigned by the Project Manager.

• Gather and report project status updates for designated regions both internally and externally.

• Create and revise project planning documents, essential study documents, and project manuals/instructions.

• Manage and report Key Performance Indicators for designated countries and clinical project team members.

• Ensure that project timelines and subject enrollment targets are achieved.

• Coordinate the maintenance of study-specific and corporate tracking systems.

• Facilitate site contractual startup and budget negotiations.

• Establish communication channels within the project team and supervise the performance of clinical project team members.

• Identify, escalate, and resolve issues related to resources and performance.

• Conduct and oversee therapeutic area training for the project team when assigned.

• Prepare presentations and lead Investigator training sessions.

• Ensure team compliance with the project-specific training matrix.

• Perform field training for Monitors tailored to the needs of the project.

• Supervise the preparation, execution, and reporting of site selection, site initiation, routine monitoring, and closeout visits.

• Oversee investigator and site payments, CRF data retrieval/upload, monitoring, and query resolution.

• Supervise the project team's preparation for study audits/inspections and the resolution of findings.

• Coordinate supervised monitoring visits.

• Review site visit reports to ensure adherence to monitoring and reporting standards.

• Coordinate initial and follow-up Regulatory and Ethics Committee submissions and notifications.

• Oversee the flow of safety information and participate in feasibility research.

• Review and approve project-related expenses and timesheets when assigned by the Project Manager.

⛳️ Requirements

• A College/University degree in Life Sciences or a comparable combination of education, training, and experience is essential.

• Previous experience in Clinical Research and on-site monitoring is necessary.

• Prior monitoring experience within the US is required.

• Experience as a Study Manager/Clinical Trial Manager with the capability to supervise project activities as a Regional Lead or equivalent is essential.

• Experience in Oncology is a must.

• Experience in GI is preferred.

• Full working proficiency in English is required.

• Proficiency in MS Office applications, including MS Project, is necessary.

• Strong communication, presentation, and customer-service skills.

• Ability to negotiate and build relationships at all levels.

• Skills in team building, leadership, and organization are essential.

🏝️ Benefits

• Employees have the option to work remotely.

• Opportunities for career advancement in clinical research.

• Continuous learning and growth within a rapidly expanding company that prioritizes its employees.