Clinical Trials Manager
Must meet all requirements for Senior Clinical Research Associate position and have demonstrated proficiency in all relevant areas. Coordinating and supervising all aspects of a clinical study. Monitors clinical trial sites. Assists Clinical Program Manager in overall study management. Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports. Maintains study timelines. Contributes to development of study budget. Contributes to development of RFPs and participate in selection of CROs/vendors. Manage CROs/vendors. Coordinates review of data listings and preparation of interim/final clinical study reports. May contribute to development of abstracts, presentations, and manuscripts Ensures effectiveness of site budget/contract process. May be asked to train CROs, vendors, investigators, and study coordinators on study requirements. Assists in determining the activities to support a projects priorities within functional area. Under supervision, may design scientific communications within the company. Travel is required.
Excellent teamwork, communication, decision-making and organizational skills are required. Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable. Must be able to generally understand, interpret, and explain protocol requirements to others. Must be able to prioritize multiple tasks. May serve as a resource for others within the company for clinical trials management expertise. Under general supervision, is able to examine functional issues from an organizational perspective. Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision. Must have a general, functional expertise to support SOP development and implementation.