Clinical Regional Project Lead

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

📋 Description

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

• Ensure uniformity of Clinical Operations processes throughout different regions.

• Guarantee that study milestones are achieved at both country and regional levels.

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

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

• Evaluate study status and report on progress when designated by the Project Manager.

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

• Create and revise project planning documents, essential study materials, 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 the upkeep of study-specific and corporate tracking systems.

• Manage site contractual startup and budget negotiations.

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

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

• Conduct and supervise training in therapeutic areas for the project team when assigned.

• Prepare presentations and provide training for Investigators.

• Ensure team adherence to the project-specific training matrix.

• Conduct field training for Monitors tailored to project requirements.

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

• Manage investigator and site payments, CRF data collection/upload, monitoring, and resolution of queries.

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

• Coordinate monitored visits.

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

• Facilitate 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 authorize project-related expenses and timesheets when delegated by the Project Manager.

⛳️ Requirements

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

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

• Prior experience monitoring within the United States is required.

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

• Experience in Oncology is a must.

• Experience in Gastrointestinal (GI) studies is preferred.

• Full working proficiency in English is required.

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

• Strong communication, presentation, and customer service abilities.

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

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

🏝️ Benefits

• Employees have the option to work remotely.

• Opportunities for career advancement in clinical research.

• Chance to learn and grow within a rapidly expanding company that prioritizes its employees.