Regional Project Lead

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

📋 Description

• Plan, execute, and oversee projects while ensuring adherence to industry regulations, ICH-GCP, essential study documents, and controlled documentation.

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

• Evaluate study progress and provide status reports.

• Gather and communicate project status updates for assigned regions.

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

• Manage and report Key Performance Indicators (KPIs) for specified countries and clinical project team members.

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

• Coordinate corporate tracking systems and study-specific processes.

• Facilitate 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 address resource and performance challenges.

• Conduct or oversee training in therapeutic areas and prepare presentations for investigators.

• Ensure adherence to project-specific training matrices.

• Provide field training for monitors.

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

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

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

• Organize monitored visits and review site visit reports.

• Coordinate submissions and notifications to Regulatory and Ethics Committees.

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

• Review and approve project expenses and timesheets as delegated.

⛳️ Requirements

• Bachelor’s degree in Life Sciences or a comparable combination of education, training, and experience.

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

• Proven experience as a Study Manager/Clinical Trial Manager with the capability to supervise project activities as a Regional Lead or similar role.

• Therapeutic expertise in Oncology and/or Gastroenterology.

• Full working proficiency in English.

• Proficient in MS Office applications, including MS Project.

• Strong communication, presentation, and customer service skills.

• Ability to negotiate and cultivate relationships at all levels.

• Skills in team building, leadership, and organization.

• Must not require a work visa for current or future employment.

🏝️ Benefits

• Flexible working arrangements.

• Opportunities for career growth and professional development.

• Chances to lead intricate global studies.

• A collaborative, people-first culture.

• Stability within the organization with long-term career opportunities.

• Engaging work that contributes to delivering innovative therapies to patients worldwide.