Project Manager at Syneos Health managing interdisciplinary clinical research studies. Ensuring compliance and leading project teams to deliver quality results.
Responsibilities
Manages a project as a project manager overseeing interdisciplinary clinical research studies
Ensures compliance with GCP, relevant SOP’s, and regulatory requirements
Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout
Lead project team to ensure quality, timelines and budget management
Accountable for the financial performance of each project
Coordinates activities and deliverables of all study conduct partners and proactively identifies and manages issues
Ensures studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements
Accountable for all project deliverables for each project assigned
Responsible for quality and completeness of TMF for assigned projects
Accountable for maintenance of study information on a variety of databases and systems
Responsible for study management components of inspection readiness for all aspects of the study conduct
Oversight for development and implementation of project plans
Plans, coordinates and presents at internal and external meetings
Prepares project management reports for clients and management
Develops contingency planning and risk mitigation strategies
Requirements
Bachelor’s Degree (or equivalent) 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
Prior experience as Project Manager in a CRO environment is required
Prior experience in Phase IV is a plus
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%)
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