Regional Project Lead

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

📋 Description

• Ensure the effective execution of clinical trials across various countries.

• Collaborate with Project Managers, CRAs, sponsors, and interdisciplinary teams.

• Strategize, execute, and oversee projects while adhering to industry regulations, ICH-GCP, essential study documents, and controlled documents.

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

• Assess study status and provide progress reports.

• Gather and communicate project status updates for assigned regions.

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

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

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

• Oversee study-specific and corporate tracking systems.

• Facilitate site contractual startup and budget negotiations.

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

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

• Conduct or oversee training in therapeutic areas.

• Prepare presentations and provide training for Investigators.

• Ensure adherence to project-specific training matrices.

• Conduct field training for Monitors.

• Oversee site selection, initiation, monitoring, and closure visits.

• Manage investigator and site compensation, CRF data collection/upload, monitoring, and query resolution.

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

• Coordinate monitoring visits and evaluate site visit reports.

• Manage submissions and notifications for Regulatory and Ethics Committees.

• Oversee the 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 mandatory.

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

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

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

• Full working proficiency in English is required.

• Proficiency in MS Office applications, including MS Project.

• Strong communication, presentation, and customer service skills.

• Capacity to negotiate and cultivate relationships at all levels.

• Team building, leadership, and organizational skills are essential.

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

🏝️ Benefits

• Flexible working arrangements.

• Opportunities for career growth and professional development.

• The chance to lead complex global studies.

• A collaborative, people-first culture.

• A stable organization where long-term careers can flourish.

• Meaningful work that contributes to bringing innovative therapies to patients worldwide.