Clinical Regional Project Lead

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

📋 Description

• Oversee, manage, and coordinate activities of clinical trial project teams in assigned countries.

• Ensure uniformity of Clinical Operations processes across various regions.

• Guarantee that study milestones, timelines, and subject enrollment objectives are achieved.

• Plan, execute, and manage projects in accordance with industry regulations, ICH-GCP, essential study documents, and relevant quality system documents.

• Serve as the primary or secondary point of contact for project management teams and PSI support services.

• Review the status of studies and deliver progress reports.

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

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

• Manage and report on key performance indicators for assigned countries and clinical project team members.

• Coordinate study tracking systems, site contractual startup processes, 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 or supervise training in the therapeutic area and for Investigators.

• Ensure adherence to project-specific training matrices.

• Provide field training for Monitors tailored to project requirements.

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

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

• Supervise preparations for study audits/inspections and the resolution of findings.

• Coordinate supervised monitoring visits and examine site visit reports.

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

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

• Review or authorize project-related expenses and timesheets when delegated.

⛳️ Requirements

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

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

• Previous experience with monitoring in the US is required.

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

• Experience in Oncology is required.

• Experience in Gastrointestinal (GI) studies 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 are essential.

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

• Strong team-building, leadership, and organizational capabilities are required.

🏝️ Benefits

• Flexible remote work options.

• Opportunities for career advancement.

• Chance to learn new skills and knowledge.

• Work with a company that prioritizes its employees.