Clinical Trials coordinator
hace 1 semana
About the role
The Clinical Trials Coordinator
plays a critical role in ensuring the seamless delivery of investigational products for clinical trials across all phases (I–IV). By designing and executing global supply strategies, the SCL ensures that clinical studies are supported with the right materials at the right time, balancing cost, risk, and regulatory compliance.
This role directly contributes to the organization's success by:
· Enabling efficient clinical supply development through proactive supply planning and risk mitigation.
· Driving operational excellence across the end-to-end supply chain—from active pharmaceutical ingredient (API) to delivery to clinical sites.
· Influencing study design with innovative packaging, labelling, and distribution solutions.
· Leading cross-functional teams to align and execute supply strategies with program goals and regulatory expectations.
Ultimately, the SCL ensures that patients receive investigational treatments on time, supporting the advancement of new therapies and the organization's mission to deliver breakthroughs that change lives.
Roles and Responsibilities
- Lead the development and execution of global investigational product supply strategies for clinical studies.
- Serve as the primary point of contact for clinical supply planning and execution, collaborating with cross-functional teams and external partners.
- Develop clinical supply chain strategies to meet study milestones, regulatory compliance, and ensure patient safety.
- Lead a multi-disciplinary matrix team to support key clinical studies milestones.
- Align supply plans with clinical protocols and operational needs.
- Anticipate changes in study design (e.g., countries, sites, enrollment) and adjust supply strategies accordingly.
- Identify and mitigate supply chain risks; develop contingency plans.
- Manage clinical trial drug supply budgets and communicate forecasts.
- Maintain accurate project data in tracking systems.
- Ensure compliance with regulatory and quality standards.
- Represent clinical supply in audits and inspections.
- Contribute to continuous improvement initiatives and limited-duration teams.
· Attend periodic meetings with teams in other global time zones outside of normal work hours.
Minimum requirements
· Bachelor's degree with at least 5 years of experience; OR a master's degree with at least 3 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience
- Bachelor's degree in supply chain, scientific discipline, project management, or business administration
- 5+ years of experience in pharmaceutical or biotech project management and cross-functional team leadership
· Demonstrated understanding of pharma quality and regulatory framework.
- Demonstrated success in matrix team environments with strong collaboration and accountability
- Excellent English communication skills (written and verbal)
- Proficiency in Microsoft Office tools, including MS Project and Office Timeline-Pro
- Flexibility to work across global time zones
Preferred qualifications
- Knowledge of Good Manufacture Practice (GMP), Good Clinical Practice (GCP), and regulatory frameworks
- Proven ability to manage complex clinical development programs and multiple studies
- Background in drug development or clinical study logistics (e.g., randomization, packaging, labeling, distribution)
- Strong budgeting and forecasting skills, including supply demand planning
- Skilled in stakeholder alignment, negotiation, and performance measurement
Experience presenting at conferences or large forums
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