Role Overview
Lead the planning and delivery of clinical trials, serving as the main project-level contact for the sponsor and coordinating a multidisciplinary team across scope, schedule, budget, and quality. You will translate commitments into clear expectations, manage risks and vendor contributions, and help ensure that trial activities meet contractual, regulatory, and organizational requirements.
Key Responsibilities
- Act as the primary point of contact between the sponsor and the organization for assigned projects, maintaining clear and consistent communication.
- Lead cross-functional teams in delivering project milestones and agreed outcomes within approved timelines, budgets, and quality standards.
- Set and manage sponsor expectations, establish appropriate communication and escalation routes, and ensure project concerns are raised through the right channels.
- Define responsibilities and communication arrangements with regional, vendor, or other secondary project leads when delivery requires shared leadership.
- Monitor project finances by understanding contract terms, aligning resources with budget, addressing out-of-scope work, and leading change-order discussions and follow-through.
- Oversee vendors throughout the project lifecycle, coordinating their work and addressing performance or delivery issues.
- Identify project risks early, resolve issues or escalate them as needed, and use sound judgment in complex or changing situations.
- Ensure project teams follow applicable organizational policies, standard operating procedures, ICH-GCP, regulatory requirements, and study-specific procedures.
Requirements & Qualifications
- Bachelor’s degree or equivalent, together with relevant academic or vocational qualifications.
- At least eight years of comparable experience, with a minimum of five years working as a Global Lead Project Manager conducting clinical trials.
- Several years of experience managing and overseeing vendors end to end across a broad range of vendor types.
- Experience in oncology, gastrointestinal, or neuroscience is preferred.
- Strong knowledge of project management fundamentals, including scope, time, quality, cost, and project-level financial management.
- Advanced understanding of therapeutic areas, clinical development, and applicable guidelines and directives.
- Ability to organize and delegate work, prioritize competing demands, and adapt effectively when project needs change.
- Clear written, verbal, and presentation skills; strong interpersonal and customer-service skills; and the ability to lead and motivate cross-functional teams.
- Demonstrated critical thinking, analytical decision-making, negotiation, persuasion, and influencing skills, with cultural awareness when working across teams.
- Proficiency with Microsoft Outlook, Word, Excel, and PowerPoint, as well as relevant organizational systems.
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