Trial Delivery Specialist – Clinical Trial Coordinator

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

📋 Description

• Collaborate with the global study leader to oversee study execution and advancement.

• Identify, address, and escalate risks that may impact study quality, timelines, and budget constraints.

• Assist in the comprehensive operational delivery of studies from setup to archival.

• Establish and maintain internal systems, databases, tracking tools, and project plans.

• Evaluate clinical documents, including protocols and informed consent forms.

• Aid in the development of plans for monitoring, vendor management, protocol deviations, and risk management.

• Coordinate activities related to the study and facilitate communication among cross-functional teams.

• Organize and schedule meetings.

• Facilitate interactions with regulatory teams, local operating companies (LOC), contract research organizations (CROs), and third-party vendors.

• Support oversight at the country level, including recruitment, data completeness, compliance, local budgeting, protocol deviations, and import license status.

• Manage vendor relationships and provide oversight for CRO activities.

• Supervise vendor deliverables specific to the study.

• Oversee the delivery of clinical supplies, investigational products, and study materials.

• Monitor the completeness of the electronic Trial Master File (eTMF) and its inspection readiness, including setup, periodic reviews, follow-up on missing documents, and dissemination of safety reports.

• Manage change orders and expenses, ensuring alignment between systems and agreements.

• Escalate financial and operational challenges to study stakeholders.

⛳️ Requirements

• A graduate or bachelor's degree in life sciences or a related field.

• Minimum of 1+ years of relevant experience in a pharmaceutical or scientific setting.

• Fundamental understanding of clinical study delivery processes, including regulatory requirements and industry standards.

• Strong project management capabilities.

• Exceptional verbal and written communication skills in English.

• Good understanding of applicable clinical trial regulatory requirements.

• Ability to handle multiple competing priorities and work autonomously.

• Excellent coordination and communication skills as a collaborator.

• Proficient in Microsoft Office applications and clinical trial management systems.

🏝️ Benefits

• Comprehensive training and development programs.

• A collaborative and inclusive work environment.

• Competitive compensation and extensive benefits.

• Customized learning pathways.

• Stretch assignments to enhance skills.

• Mentorship opportunities.

• Ongoing learning and career development.

• Global exposure through international clinical studies.

• Opportunities to enhance project management, financial tracking, data analysis, and risk management skills.

• Chance to learn about clinical trial technologies, including AI platforms.