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Clinical Project Manager (RCI-ABV-15925/ 01564)

Company: Rangam Consultants, Inc.
Location: Kenosha
Posted on: May 16, 2019

Job Description:

Education - 2+ years total experience in the Pharmaceutical Industry. Looking at experience in one of the following areas: Drug discovery (eg, Process Chemistry, Analytical Chemistry) Drug development (eg, Formulation) Clinical operations (eg, Clinical Project Management) Supply chain (eg, Clinical Supplies Project Management) Quality Assurance looking for project management experience. Does not need to be directly related. Good communication skills essential. This position may not keep the interest of someone coming from a director level position. This position does not have direct reports. Bachelors Degree required, preferably in physical science, math, engineering, or pharmacy. Some experience desirable in a lab environment, at a research site, drug development, clinical operations, quality assurance, supply chain. Responsibilities Responsible for the project management of key Clinical Supply Chain activities at the protocol level for pre-clinical and Phase I II clinical trials generally of less complexity, Includes forecasting, planning, scheduling, coordination, and execution, ensuring timely availability of investigational drug supplies and related services to clinical sites and depots. Provides input to Clinical Study Teams to influence clinical protocol design to ensure most efficient utilization of supply chain resources. Translates clinical study design into packaging design. Authors the study medication and labeling section of the clinical protocol. Develops protocol specific labeling compliant with applicable global regulations. Identifies, develops, communicates and tracks project timelines, activities, logistics, and milestones. Responsible for creating appropriate protocol specific manufacturing and packaging work orders in concert with Third Party and IVRS vendors, QA, clinical team partners etc to ensure timely availability of clinical supplies. Responsible for protocol-specific clinical supplies scenario analysis, risk management, and contingency planning. Forecasts protocol specific bulk drug product requirements, including comparator agents, ancillary supplies, and commodities, including overages. Manage Phases I IV domestic and international clinical research studies. Responsibilities include protocol design and development, case report form development, contract negotiation, site recruitment, support program management for project reviews, budget and timeline development, establish relationships with outside vendors, medical consultants and partners, provide IND and NDA summary reports, interface with interdisciplinary teams, monitor project timelines, develop project management tools, and provide project presentations. 0-3 Years Experience Level.

Keywords: Rangam Consultants, Inc., Kenosha , Clinical Project Manager (RCI-ABV-15925/ 01564), Executive , Kenosha, Wisconsin

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