Clinical Project Director managing a portfolio of clinical studies to meet client-specific needs at Syneos Health. Ensuring compliance with quality standards and delivering project objectives effectively.
Responsibilities
Oversee a portfolio or program of projects
Ensure all studies within a program or portfolio are conducted to reflect the therapeutic or client specific requirements
Represent company to the customer, ensuring satisfaction levels are maintained and program deliverables are communicated effectively
Ensures the study is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) or appropriate regulatory requirements, and International Conference on Harmonization (ICH) guidelines to fulfil all federal and local regulations
Manages the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses
Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools
Ensure and maintain an in depth therapeutic and/or client specific knowledge and expertise for the assigned portfolio
Apply study specific learning across assigned portfolio of studies/clients
Lead and ensure consistency in contingency planning and risk mitigation strategies to ensure successful delivery
May lead operational input to proposal development and pricing including proposed operations strategy
Drive performance improvement, operational efficiencies and innovative strategies
May provide line management oversight and contribute to leadership of Project Management as an operational and therapeutic area expert
Requirements
BA/BS in the life sciences, nursing degree, or equivalent combination of education and experience
Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements, i.e. GPP
Strong organizational skills
Strong ability to manage time and work independently
Direct therapeutic area expertise
Proficiency with full MS Office Applications, including MS Project
Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
Ability to travel as necessary (approximately 25%)
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