Company
Biotech
RegionalProjectLead
Neural analysis suggests this role is
optimal for Senior candidates.
“Regional Project Lead. Skills: clinical trial management, project management, Oncology clinical research, ICH-GCP guidelines, English. 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 througho”
What You'll Achieve.
Opportunity to lead complex, high-impact clinical research projects across multiple regions and countries. Opportunity to work on studies that contribute to the development of new treatments and therapies.
Industry & Context.
risk management; stakeholder coordination
Must be legally authorized to work in the United States without current or future visa sponsorship requirements.
What They're Looking For.
Must Have
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. background in Oncology clinical research is required. Full professional proficiency in English, with excellent verbal and written communication skills. Must be legally authorized to work in the United States without current or future visa sponsorship requirements.
Nice to Have
Experience within Gastrointestinal (GI) therapeutic areas is considered an advantage.
What You'll Do.
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.
How You'll Work.
Team & Collaboration
Serve as a key project management contact for regional teams and internal support functions, facilitating effective communication and collaboration throughout the study lifecycle. Access to global project teams and cross-functional collaboration opportunities.
Communication Scope
verbal communication; written communication
Process & Methodology
planning, reporting, risk management, stakeholder coordination
Full Job Description
## Accountabilities 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. Requirements 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 bac
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