Beschreibung

As a Senior Clinical Project Manager, you will lead complex clinical trials, ensuring compliance and quality while mentoring others. This role involves managing timelines, risks, and budgets, while collaborating with various teams to drive successful study execution.

Anforderungen

• •Bachelor's degree in life sciences or relevant technical areas
• •Minimum 4 years project management experience
• •Minimum 6 years of clinical study experience in medical device, IVD, pharmaceutical, biotechnology, or CRO
• •Familiarity with CLSI guidelines and other standards
• •Demonstrable Project Management skills; PMP Certification preferred
• •Proficient understanding of Good Clinical Practice (GCP), FDA and ISO regulations, MDR/IVDR
• •Knowledge of clinical trial concepts and practices
• •Strong client and vendor relationship management skills
• •Ability to work effectively in international teams and manage multiple projects
• •Effective interpersonal, communications and negotiation skills
• •Ability to work effectively in a virtual environment
• •Ability to travel approximately 20%, worldwide

Aufgaben

• •Manage clinical trials for multiple studies
• •Serve as a subject matter expert for assigned clinical studies
• •Plan and implement clinical trial activities
• •Oversee project management and completion of trials
• •Mentor Clinical Project Managers and CRAs
• •Lead high-complexity studies from protocol development to closeout
• •Ensure compliance with Good Clinical Practices and regulations
• •Collaborate with the Clinical Program Manager and Director
• •Review business requests and develop study execution plans
• •Identify and manage project risks and issues
• •Collaborate with global project management, data management, and statistics
• •Work with Medical Affairs departments on study-related activities
• •Train local clinical resources and oversee contractors
• •Implement high-quality standards for study compliance
• •Contribute to continuous improvement initiatives
• •Manage relationships with sites, PIs, and vendors
• •Develop and oversee clinical study budgets
• •Review and approve invoices and monthly accruals
• •Track and report on project management schedules and deliverables