Senior Project Manager(m/w/x)

Anforderungen

• BS/BA from an undergraduate program in life sciences or related discipline or equivalent experience
• 10 years of experience in pharmaceutical/biotechnology/CRO industry with at least 5 years of clinical project management experience
• Carefulness, thoroughness, and attention to detail
• Strong organizational skills and ability to multi-task in a fast-paced environment
• Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
• Self-starter thriving in a collaborative, less structured team environment
• Ability to problem-solve unstructured or ambiguous challenges
• Strong command of English, both written and verbal
• Excellent communication and interpersonal skills with customer service orientation
• Proficiency with MS Office Suite, particularly Word and Excel
• Permanent authorization to work in the U.S.

Aufgaben

• Manage clinical research studies according to approved scope, budget, ICH GCP guidelines, and FDA regulations
• Serve as the study lead and primary contact for sponsors
• Oversee clinical study functions, including investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory
• Generate and present frequent study status updates and reports to sponsors
• Supervise and support the Clinical team, including Clinical Assistants and Clinical Research Associates
• Train Associate CPMs and provide ongoing support to CPMs
• Create and review clinical study documents, including protocols and study budgets
• Drive and facilitate clinical teamwork and communications to achieve trial milestones
• Ensure accuracy of reports and work products
• Provide monthly billing information to the finance team
• Present at project meetings, including investigator and new client meetings
• Update management regularly through frequent communication
• Identify issues and develop problem-solving strategies to meet study timelines
• Manage subject accrual, retention, and compliance
• Assist in TMF management and conduct TMF reviews as needed
• Prepare for and participate in third-party audits and FDA inspections
• Ensure compliance with ICH GCP guidelines, FDA regulations, and company SOPs
• Participate in internal, client/sponsor, scientific, and other meetings as required
• Perform additional duties as assigned

Berufserfahrung

Ausbildung

Sprachen

Tools & Technologien