Clinical Study Manager (Park Ridge, NJ)

Primary Responsibilities:
-Support a phase II clinical trial in study start-up, including but not limited to, as outlined below:
-Experience in managing all aspects of study progress from start-up 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
-Experience in coordinating interdisciplinary activities involving study start-up: investigator meeting planning, case report form development, study drug supply design and ordering, development of contracts and budgets, data base set-up, regulatory document filing
-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

-Bachelor’s degree in biological science, nursing, pharmacy or equivalent as a minimum
-Minimum 5 years experience in the pharmaceutical industry in a position performing clinical operations functions
-Strong communication skills
-Oncology experience a plus

Type: Long-term Contract