Project Manager II

• Manage interdisciplinary clinical research studies as a project manager
• Ensure compliance with GCP, relevant SOPs, and regulatory requirements
• Act as primary liaison between the Company and the Customer for study launch, conduct, and closeout
• Lead project teams and manage quality, timelines, and budgets
• Manage project financial performance
• Coordinate study conduct partners and proactively identify and manage issues
• Oversee project deliverables and TMF quality and completeness
• Maintain study information across databases and systems
• Manage inspection readiness for study conduct
• Develop and implement 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
• Build client relationships to generate future business
• Participate in bid defense meetings when presented as a potential project manager
• Potentially 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, 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
• Reasonable accommodations, when appropriate, for employees or applicants with disabilities