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Clinical Trial Manager
Ref No.: 15-03676
Location: Bridgewater, New Jersey
Duties:
The Clinical and Exploratory Pharmacology (CEP) Clinical Trial Manager (CTM) is responsible for the overall operational planning and activities for the implementation and conduct of early phase clinical trials in compliance with ICH, GCP's, SOPs, local requirements, internal/departmental guidelines, and established timelines. The CTM is involved in the operational planning and scientific conduct of the clinical trial and acts as the leader of operational disciplines (Clinical Trial Team (CTT)) to guarantee release of homogeneous high quality clinical data in close collaboration with the CEP Data Manager (DM) and Clinical Study Director (CSD).

The CTM may manage studies at the product level (if applicable). The CTM can be involved in field monitoring activities of his/her own studies according to workload/need and/or manages local monitoring or outsourced monitoring. The CTM may also participate in intra or inter-department Working Groups.

The job may include international responsibilities.

Skills:
Previous experience with medical terminology (basic knowledge in medicine is preferred, including laboratory procedures/techniques and biological knowledge) and GCP/ICH Guidelines
Experience in global patient studies with vendor management. General understanding of R&D processes including the principals of study design and execution
Capability of interacting effectively with scientists and managers from various disciplines on an international basis
Ability to serve as internal consultant on assigned area and liaise with external organizations on projects
Good interpersonal and communication skills (verbal and written)
Self-motivation, flexibility, attention to detail and organizational skills, goal-oriented
Ability to build optimal collaboration within the company and with external partners
Ability to work in a team environment

Project Management skills
Experience with various computer systems/database; a willingness to learn new systems/databases
Results-driven in terms of timelines and quality
Experience in early phase clinical development preferable

Education:
Bachelor's Degree + 8+ yrs. laboratory or medical experience

5+ years in clinical research