Contract - Manager, Clinical Research

Job Advertised by Pharmadiversity Job Board - Overall Purpose: Responsible for the management of Phase I-IV clinical trials within defined timelines, budgets and resource allocations. Ensures compliance with FDA, ICH and ISTA SOPs. Interacts extensively with other departments within ISTA and external partners including investigational sites, Contract Research Organizations (CRO) and other vendors. May have multiple clinical studies to manage simultaneously. Some or all of the responsibilities may be delegated to a CRO. May also be responsible for management and supervision of other clinical operations staff. Duties & Responsibilities: Ensures clinical studies are completed within corporate timeframes. This includes creation, tracking, and management of study timelines, determination of risk factors, and prompt notification to study team and upper management of potential issues. Responsible for financial management of assigned clinical studies, including study budgeting, forecasting, determination of month-end accruals, monitoring study related expenses, promptly identifying and reporting budget variances (including out-of-scope activities), processing of study-related invoices, etc. Manages internal and external resources assigned to the study team. Participates in the initial determination of resource needs for the study. Coordinates activities associated with the identification, evaluation and selection of Contract Research Organizations (CROs), contractors, consultants and other external vendors. Once selected, responsible for the management of these individuals/groups. Coordinates investigator identification, evaluation and selection process. Determines investigator budgets ensuring timely completion of clinical study agreements and investigator grant payments. May be involved with negotiations. Leads Clinical Operations (CO) team, supervises CO team activities, provides training and development support to direct reports. Attends project team meetings, communicates study status, identifies potential issues and proactively presents possible solutions. Effectively interacts and communicates with other department team members, external departments and external vendors/partners regarding activities associated with the conduct of the study. Effectively interacts and communicates with the head of Clinical Operations providing timely updates on the progress and changes in scope, schedule and resources. Manages the development and approval process for critical study documents (e.g. protocol, amendments, ICF, CRFs, various study plans, study specific procedures, etc.) ensuring quality documents are produced. Manages all clinical and non-clinical supplies. Responsible for the development of enrollment strategies, site-level contingency planning, implementation of rescue strategies where needed, Manages the processing of clinical data ensuring data is entered, verified, queried and coded in a timely manner. Also oversees database.... br/ br/ * For application attention if web source is requested please use PharmaDiversity or PharmaDiversity Job Board. br/ br/ APPLY FOR THIS JOB by going to ...http://www.pharmadiversityjobboard.com/view_job.php?post_id=583744&tag=aje