Regional Project Lead

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

📋 Description

• Plan, execute, and oversee clinical research initiatives while adhering to industry standards, ICH-GCP guidelines, essential study documentation, and relevant controlled documents.

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

• Assess study progress and communicate updates.

• Gather and relay project status updates for specific regions, both internally and externally.

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

• Manage and report on KPIs for specific countries and members of the clinical project team.

• Ensure adherence to project timelines and subject enrollment objectives in the designated countries.

• Coordinate study-specific and corporate tracking systems.

• Handle site contractual startup processes and budget negotiations.

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

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

• Conduct or oversee training related to therapeutic areas and Investigator training.

• Ensure compliance with project-specific training matrices.

• Conduct field training for Monitors.

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

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

• Supervise preparations for study audits/inspections and address any findings.

• Coordinate supervised monitoring visits and review site visit reports.

• Manage Regulatory and Ethics Committee submissions and notifications.

• Ensure effective flow of safety information and engage in feasibility research.

• Review and approve project expenses and timesheets when authorized.

⛳️ Requirements

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

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

• Experience as a Study Manager/Clinical Trial Manager with the ability to oversee project activities as a Regional Lead or equivalent is required.

• Therapeutic expertise in Oncology and/or Gastroenterology is mandatory.

• 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 foster relationships at all levels.

• Team-building, leadership, and organizational skills are critical.

• Must not require a work visa for employment or continued employment now or in the future.

🏝️ Benefits

• Flexible working arrangements.

• Opportunities for career advancement and professional development.

• Potential to lead complex global studies.

• A collaborative, people-first organizational culture.

• A stable organization that supports long-term career growth.

• Engaging work that contributes to advancing innovative therapies for patients.