Responsibilities:

·         Organize and facilitate the overall planning, coordination, tracking, and general performance of clinical studies that support the Clinical Development Plan. 

·         Ensure clinical study quality/consistency of performance and in conjunction with the Clinical Leader and all other Team members is responsible for overall timeline adherence and performance against plan of the clinical study. 

·         A critical component of the position is the peer management and/or support of coordination with contract research organization personnel (CROs), consultants, contractors, and other colleagues to ensure adequate resource volume and quality is maintained.

·         Conduct the following (or manage the CRO) with minimal supervision in accordance with ICH/GCP/FDA guidelines, policies/SOPs/WPDs, and protocol specifications:

·         Review protocols and advise regarding logistics involved in the conduct of the protocol.

·         ICF development and review.

Experience:

·         BS/BA in a health-care or science related field with a minimum of 7+ years of related experience in a pharma or CRO company. 

·         Demonstrated knowledge of and competence in application of FDA/GCP/ICH guidelines.

·         Demonstrated the use of excellent communication skills, command of medical terminology and of the application of scientific/medical and clinical concepts used to conduct Phase I-IV clinical trials.

·         Demonstrated knowledge and ability to effectively manage a clinical trial with minimal supervision.

·         Demonstrated ability to lead cross-functional teams, excellent organization, negotiation, and team motivation skills are essential.

·         Superior written and verbal communication skills, peer management skills and must have a well-defined, effective system for multi-tasking required.