Beschreibung

As a Senior Project Manager, you will lead clinical research studies, ensuring alignment with regulatory guidelines and timelines. Your role involves managing teams, communicating with sponsors, and driving project success through effective collaboration and problem-solving.

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

Tools & Technologien