Project Manager II

• Manage interdisciplinary clinical research studies as a project manager
• Ensure compliance with GCP, relevant SOPs, and regulatory requirements
• Act as the primary liaison between the Company and Customer
• Ensure timely study launch, conduct, and closeout
• Lead project teams to manage quality, timelines, and budgets
• Manage project financial performance
• Coordinate study conduct partners and proactively identify and manage issues
• Ensure accountability for project deliverables
• Maintain quality and completeness of the TMF
• Maintain study information in databases and systems
• Manage inspection readiness for study conduct
• Oversee development and implementation of project plans
• Plan, coordinate, and present internal and external meetings
• Prepare project management reports for clients and management
• Develop contingency plans and risk mitigation strategies
• Develop client relationships to generate future business
• Participate in bid defense meetings when presented as a potential project manager
• May line manage project management team members and clinical monitoring staff

• Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience
• Clinical research organization (CRO) and relevant therapeutic experience preferred
• Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
• Strong organizational skills
• Strong ability to manage time and work independently
• Direct therapeutic area expertise
• Ability to embrace new technologies
• Excellent communication, presentation, and interpersonal skills, both written and spoken
• Ability to travel as necessary (approximately 25%)

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Inclusive culture where employees can authentically be themselves