We are a Large Clinical Research Organization who have offices all over the world. We provide clinical development services to the biotechnology, pharmaceutical and medical device industries. Our end goal is to speed-up the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We have local regulatory and therapeutic expertise across all major areas including oncology, cardiology, central nervous system, anti-viral and anti-infective. We have over 4000 employees all over the globe.
Responsibilities:
Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations
Serve as primary Sponsor contact for operational project-specific issues and study deliverables
Maintain your strong knowledge of protocol, therapeutic area, and indication
Provide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is provided
Review and give your input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable
Make operational project plans
Responsible for management of study vendor
Manage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables
Qualifications:
Bachelor’s degree in a health-related field; Advanced degree in a health-related field preferred
Experience in Phases 1-4; Phases 2-3 is preferred
5+ years as a project/clinical trial manager within a CRO, Required Homebased
Management of overall project timeline
Strong leadership skills
By uploading your CV it will be sent to Luke at Barrington James. Luke is a Specialist Clinical Operations/Development Recruiter with a strong background in recruitment and the life science field. Luke will discuss the opportunity in detail with you, facilitate your application and will manage the process acting as a link between the company and yourself. He will assist in all elements of the process, facilitate the offer process, keep in contact throughout your notice period and even catch up with you during your first week in your new role.