Clinical Regional Project Lead

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

📋 Description

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

• Ensure uniformity of Clinical Operations processes across various regions.

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

• Plan, implement, and oversee projects in accordance with 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 the status of studies and report on progress.

• Gather and provide updates on project status both internally and externally.

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

• Manage and report on Key Performance Indicators (KPIs).

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

• Coordinate the maintenance of study-specific and corporate tracking systems.

• Facilitate site contractual startup and budget negotiations.

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

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

• Conduct and manage training in therapeutic areas.

• Prepare presentations and deliver Investigator training.

• Ensure adherence to the project-specific training matrix.

• Conduct field training for Monitors.

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

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

• Oversee project team preparations for study audits/inspections and address any findings.

• Coordinate supervised monitoring visits.

• Review site visit reports and ensure that 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 authorized.

⛳️ Requirements

• A College/University degree in Life Sciences or an equivalent 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 as a Regional Lead or equivalent is necessary.

• Experience in Oncology is required.

• Experience in GI is preferred.

• Full working proficiency in English is a must.

• Proficient in MS Office applications, including MS Project.

• Strong communication, presentation, and customer service skills.

• Ability to negotiate and foster relationships at all levels.

• Team building, leadership, and organizational abilities.

🏝️ Benefits

• Options for remote work.

• Opportunities for career advancement.

• Possibility to learn new skills.

• A company culture focused on employees.