Clinical Regional Project Lead

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

📋 Description

• Manage, oversee, and coordinate activities of project teams in assigned countries, ensuring uniformity of Clinical Operations processes across various regions.

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

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

• Review the status of studies and provide progress reports as delegated by the Project Manager.

• Gather and communicate project status updates for specified regions to both internal and external stakeholders.

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

• Manage and report on KPIs for designated countries and clinical project team members.

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

• Coordinate study-specific and corporate tracking systems.

• Facilitate site contractual startup and budget negotiations.

• Establish communication lines for the project team and oversee the performance of clinical project team members.

• Identify, escalate, and address resource and performance issues.

• Conduct or oversee training in therapeutic areas and prepare presentations for Investigators.

• Ensure adherence to project-specific training matrices.

• Provide field training for Monitors tailored to project requirements.

• Oversee site selection, initiation, routine monitoring, and closeout visits.

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

• Supervise preparations for study audits/inspections and address any findings.

• Coordinate monitored visits and review site visit reports.

• Manage initial and follow-up submissions and notifications to Regulatory and Ethics Committees.

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

• Review and authorize project-related expenses and timesheets as delegated by the Project Manager.

⛳️ Requirements

• Bachelor's degree in Life Sciences or an equivalent combination of education, training, and experience.

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

• Prior experience monitoring within the United States.

• Experience as a Study Manager/Clinical Trial Manager, capable of supervising project activities as a Regional Lead or similar role.

• Background in Oncology.

• Full working proficiency in English.

• Proficiency in MS Office applications, including MS Project.

• Strong communication, presentation, and customer service skills.

• Ability to negotiate and build relationships across all levels.

• Team-building, leadership, and organizational skills.

🏝️ Benefits

• Remote work opportunities.

• Prospects for career advancement.

• Active involvement in all facets of clinical studies.

• Opportunity to lead complex full-service projects.

• Join a company that prioritizes its people.