Clinical Regional Project Lead

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

📋 Description

• Oversee, manage, and coordinate activities of clinical trial project teams in assigned countries while ensuring the uniformity of Clinical Operations processes across various regions.

• Ensure that study milestones, timelines, and subject enrollment targets are achieved at both country and regional levels.

• Plan, implement, and manage projects in accordance with 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 designated countries.

• Review the status of studies and provide progress reports.

• Gather and report project status updates both internally and externally.

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

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

• Coordinate study-specific and corporate tracking systems.

• Facilitate site contractual startup and budget negotiations.

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

• Identify, escalate, and resolve resource and performance-related issues.

• Conduct or oversee therapeutic area training and Investigator training.

• Ensure adherence to project-specific training matrices.

• Provide field training to Monitors.

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

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

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

• Coordinate supervised monitoring visits.

• Review site visit reports and ensure monitoring and reporting standards are upheld.

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

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

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

⛳️ Requirements

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

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

• Prior experience in monitoring within the US is required.

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

• Experience in Oncology is required.

• Experience in Gastrointestinal (GI) studies is preferred.

• Full working proficiency in English is necessary.

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

• Strong communication, presentation, and customer service skills.

• Ability to negotiate and foster relationships at all levels.

• Skills in team-building, leadership, and organizational capabilities are essential.

🏝️ Benefits

• Option for remote work.

• Direct involvement in every facet of the study.

• Opportunities for career growth.

• Work with a company that prioritizes its people.