Req Number: 1742
Title: Clinical Trial Manager
Division: Clin Dev & Reg Aff
Location: Tarrytown, N.Y.
Summary: The Clinical Trial Manager maintains accountability for the day-to-day operations of 1-4 clinical trials commensurate with complexity, including trial start-up, conduct, and close-out activities.
Essential Duties and Responsibilities include, but are not limited to the following:
'Serves as primary contact for functional area representatives in managing all aspects of protocol execution.
'Interacts regularly with CRO, central laboratory, and IVRS systems; manages scope of work and study progress.
'Follows established clinical study standards and procedures to plan and conduct clinical research studies.
'Develops procedures and tools for data collection as needed.
'Applies knowledge of company policies and standard practices to resolve problems.
'Analyzes issues and uses judgment to make decisions.
'Escalates non-standard problems or issues as may be required.
'Compiles and maintains regular status reports of study progress and study specific timelines and ensures information is provided to Clinical Trial Program Manager (CTPM).
'Develops study documents including protocols, informed consent forms, and procedure manuals.
'Maintains open communication channels with study sites and members of the study team.
'May provide guidance and serve as lead to junior CTMs or other clinical team members.
A Bachelor's degree from an accredited college or university plus minimum of seven (7) years of relevant Clinical Trial Manager and Clinical Research work/therapeutic expertise with knowledge of clinical drug development process in biotechnology or pharmaceutical industry required, or Master's degree (MS) in Life Sciences or related discipline and five (5) years of experience.
'Knowledge of GCP and ICH and US FDA regulations is a must
'Ability to develop and manage clinical program budget
'Proven management skills for CROs and Vendors
'Broad knowledge and cross-functional understanding of clinical trial methodology.
Experience in one or more of the following therapeutic areas preferred: inflammation, ophthalmology, translational medicine and oncology.
We offer an extremely competitive compensation and benefits package to all our employees, including stock incentives, 401k with company match as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.
An EOE M/F/H/V