Senior Manager, Clinical Operations 8/18/2016
Woodcliff Lake, NJ
JOB DESCRIPTIONAPPLY This position is responsible for supporting a phase 2 clinical trial in study maintenance, including but not limited to, as outlined below:
Experience in managing all aspects of study progress from maintenance activities to close-out activities to assure adherence to intended timeline to achieve study goals while ensuring good clinical practice compliance in accordance with FDA, GCP, and ICH guidelines.
Collaborate with the therapeutic area team and project management to develop strategies and meet goals/timelines set forth by the team.
Oversight and management of CRO to ensure successful conduct of the clinical trial by managing daily study activities to ensure data integrity and quality.
Communicate with study sites and third-party vendors, proactively recognizes problem situations and inform team members to enable issue resolution.
Electronic data capture experience, particularly Inform, as a plus.
Contribute to individual and team development through training initiatives and team building activities.
Bachelor's degree in biological science, nursing, pharmacy or equivalent as a minimum.
Minimum 5 years of experience in the pharmaceutical industry leading studies, with multiple vendors involving management of submission timelines and associated processes
Demonstrated experience in the identification of emerging risks and the ability to collaboratively champion solutions within a multi-disciplinary drug development team to help resolve challenges is required
Solid project and vendor management, analytical and problem solving skills
Excellent written and verbal communication skills
Experience in the CNS therapeutic area preferred, but not required.