Clinical Regional Project Lead

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

📋 Description

• Supervise, manage, and coordinate the activities of project teams across specified countries.

• Ensure uniformity of Clinical Operations processes throughout various regions.

• Guarantee that project teams achieve study milestones at both country and regional levels.

• Plan, execute, and manage projects while adhering to industry regulations, ICH-GCP, essential study documents, and relevant controlled documents.

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

• Review study progress and provide updates when assigned by the Project Manager.

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

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

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

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

• Coordinate study-specific and corporate tracking systems.

• Oversee site contractual startup and budget negotiations.

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

• Identify, escalate, and resolve resource and performance challenges.

• Conduct and oversee therapeutic area training for project teams as assigned.

• Prepare presentations and deliver Investigator training sessions.

• Ensure adherence to project-specific training matrices.

• Provide field training for Monitors customized 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 project team preparation for study audits/inspections and address findings.

• Coordinate monitored visits.

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

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

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

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

⛳️ Requirements

• A college or university degree in Life Sciences or a comparable combination of education, training, and experience is required.

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

• Prior experience in monitoring within the US is essential.

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

• Experience in Oncology is mandatory.

• Experience in Gastroenterology is preferred.

• Full working proficiency in English is required.

• Proficiency in MS Office applications, including MS Project.

• Strong communication, presentation, and customer service skills.

• Ability to negotiate and establish relationships at all organizational levels.

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

🏝️ Benefits

• Option for remote work.

• Opportunities for career advancement.

• Chance to coordinate diverse tasks and acquire new skills.

• Opportunity to develop within a rapidly expanding company that prioritizes its employees.