Clinical Project Manager

We're looking for a Clinical Project Manager (CPM) to lead the execution of clinical trials from start-up through closeout. You'll be the driving force ensuring studies are delivered on time, within budget, and in compliance with all regulatory and quality standards.

What You'll Do:

• Lead cross functional project teams to deliver high-quality clinical trials in compliance with applicable regulations and quality documents.

• Work with functional areas on initiating, planning, executing, controlling, closing and resourcing clinical trial projects
• Coordinate the development of protocols and protocol amendments in collaboration with sponsor, coordinating investigator and other experts
• Coordinate the development of study documents (e.g., informed consent forms, investigator brochures, monitoring plans).
• Participate in preparing study budgets, proposal documents
• Participate in bid defense meetings
• Handle contract/budget negotiation with sites
• Ensure deviations are managed appropriately and escalated to the sponsor as required
• Identify risks and develop and implement plans to mitigate risks in collaboration with team members and appropriate stakeholders
• Manage Data Safety Monitoring Board or other study committees
• Ensure appropriate oversight of vendors/suppliers
• Create and maintain project timelines for each project and track project's progress
• Ensure close monitoring of the clinical trial budget
• Review study metrics for performance and quality with the team and management
• Report progress to the internal and external project team and stakeholders
• Ensures review of clinical Trial Master File for completeness
• Support audits

• Master's degree in health science or equivalent
• Thorough knowledge of Good Clinical Practice
• 2+ years of experience Clinical Project Management
• Knowledge of GCP, ICH guidelines, regulatory requirements
• English fluent
• Good problem solving, decision making skills and situational judgement