Regional Project Lead in United States at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regional Project Lead based in the United States.

This is an exciting opportunity for an experienced clinical research professional to lead regional clinical trial operations across multiple countries and sites. In this role, you will oversee project execution, ensure operational excellence, and drive the successful delivery of complex clinical studies within a highly regulated environment. Working closely with cross-functional teams, investigators, sponsors, and operational stakeholders, you will play a key role in maintaining study quality, timelines, and compliance standards. The position combines strategic oversight, team leadership, and hands-on project management, offering broad exposure across all stages of the clinical trial lifecycle. Ideal for a proactive and collaborative leader, this role provides the chance to contribute directly to the advancement of innovative therapies while supporting high-performing project teams.

• Lead the planning, implementation, and management of clinical trial activities across designated countries and regions, ensuring compliance with applicable regulations, study protocols, and quality standards.
• Serve as a key project management contact for regional teams and internal support functions, facilitating effective communication and collaboration throughout the study lifecycle.
• Monitor project progress, collect and report status updates, and support study milestone tracking to ensure timelines and enrollment targets are achieved.
• Develop, maintain, and update project plans, study documentation, operational manuals, and essential trial records.
• Track and report key performance indicators (KPIs), proactively identifying risks, resource constraints, and operational challenges while implementing corrective actions when needed.
• Coordinate site startup activities, including contract negotiations, budget discussions, regulatory submissions, and ethics committee interactions.
• Supervise project team performance, provide coaching and training, and ensure compliance with study-specific training requirements.
• Oversee site monitoring activities, including site selection, initiation, routine monitoring, closeout visits, and review of monitoring reports to ensure quality and consistency.
• Support investigator training, study audits, inspections, safety reporting processes, and resolution of audit findings.
• Coordinate operational activities related to data collection, query resolution, investigator payments, tracking systems, and study documentation management.

• Bachelor's degree in Life Sciences or an equivalent combination of education, training, and relevant professional experience.
• Prior experience in clinical research and on-site monitoring within regulated clinical trial environments.
• Proven experience as a Study Manager, Clinical Trial Manager, or similar leadership role overseeing regional or multi-country clinical projects.
• Strong background in Oncology clinical research is required.
• Experience within Gastrointestinal (GI) therapeutic areas is considered an advantage.
• In-depth understanding of clinical trial regulations, ICH-GCP guidelines, and industry best practices.
• Full professional proficiency in English, with excellent verbal and written communication skills.
• Strong project management capabilities, including planning, reporting, risk management, and stakeholder coordination.
• Proficiency with Microsoft Office applications, including Microsoft Project and other project management tools.
• Excellent leadership, team-building, organizational, and decision-making skills.
• Strong negotiation, relationship management, presentation, and customer-facing abilities.
• Must be legally authorized to work in the United States without current or future visa sponsorship requirements.

• Opportunity to lead complex, high-impact clinical research projects across multiple regions and countries.
• Exposure to all phases of clinical trial management and operations.
• Collaborative and people-focused work environment that supports professional growth and career advancement.
• Hands-on involvement in strategic and operational aspects of clinical development programs.
• Access to global project teams and cross-functional collaboration opportunities.
• Continuous learning and development within a rapidly growing clinical research organization.
• Dynamic workplace focused on innovation, quality, and advancing medical science.
• Opportunity to work on studies that contribute to the development of new treatments and therapies.