Regional Project Lead

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

📋 Description

• Ensure that the planning, implementation, and management of projects adhere to industry regulations, ICH-GCP, essential study documents, and relevant controlled documents.

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

• Evaluate study status and communicate progress reports.

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

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

• Oversee and report Key Performance Indicators for specified countries and clinical project team members.

• Ensure project timelines and subject enrollment objectives are achieved.

• Manage study-specific and corporate tracking systems.

• Facilitate site contractual startup and budget negotiations.

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

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

• Conduct or oversee training in therapeutic areas for project teams.

• Prepare presentations and conduct training for Investigators.

• Ensure adherence to project-specific training matrices.

• Conduct field training for Monitors.

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

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

• Oversee preparation for study audits/inspections and address findings.

• Coordinate supervised monitoring visits.

• Review site visit reports and ensure compliance with monitoring and reporting standards.

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

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

• Review and approve project-related 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 oversee project activities as a Regional Lead or equivalent is required.

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

• Full working proficiency in English is necessary.

• Proficiency in MS Office applications, including MS Project.

• Strong communication, presentation, and customer service skills.

• Ability to negotiate and foster relationships at all organizational 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.

• Chances to lead complex global studies.

• A collaborative, people-first culture.

• A stable organization where long-term careers can be developed.

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