Jobgether
Regional Project Lead
TLDR
Lead regional clinical trial operations across multiple countries and sites, driving compliance, timelines, and cross-functional collaboration throughout the study lifecycle.
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.
- 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.
Requirements
Benefits
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
#LI-CL1
Benefits
Learning Budget
Continuous learning and development within a rapidly growing clinical research organization.
contribution to new treatments and therapies
Opportunity to work on studies that contribute to the development of new treatments and therapies.
Jobgether runs the largest remote job platform, effectively linking job seekers with over 200,000 flexible and remote opportunities that match their unique skills and preferences. Our focus is on enhancing the hiring process, ensuring efficiency while prioritizing the candidate experience, particularly in the growing health and wellness sector.
- Founded
- Founded 2020
- Employees
- 11-50 employees
- Industry
- Professional Services
Project Lead