Clinical Studies Technical Leader I

Job Description:Kimberly-Clark, a global health and hygiene leader, and our trusted brands are an indispensable part of life for 1.3 billion people in more than 150 countries. Kimberly Clark has been helping generations of families improve the quality of their lives, to ensuring the health of our employees and the environment. We believe in recruiting the best people and putting them in the right jobs so that they can do their best work. For more information about our company, visit us at . Currently, we are seeking a Clinical Studies Technical Leader I for our Roswell, GA location. Summary:The Clinical Studies Technical Leader I functions as a project manager accountable to the Clinical Director to design, implement and manage multiple clinical studies to business customers' satisfaction. They provide overall project management of clinical trials or clinical programs. Responsibilities:- Project assessment and initiation, resource procurement and planning, project implementation, leading and motivating a cross-functional team, milestone planning and tracking, ensuring that projects are progressing according to quality standards, SOPs, ICH and/or other guidelines to fulfill local regulations, production of key project progress reports, management of communications between Kimberly-Clark project team and external customers/investigators, and contract and financial management. - Developing, implementing and managing a clinical trials function that contributes to successful achievement of company global business plans and established financial goals. This effort can include but not necessarily be limited to: Participate in assessment, preparation and delivery of a comprehensive clinical affairs plan. (within 90 days) With minimal supervision, initiate, design, plan, manage and deliver results for assigned clinical projects according to applicable regulations, guidance and SOPs within agreed time frames and budget. (engage within 90 days) Identify key issues and then recommend and implement solutions within 30 to 60 days for assigned current clinical programs that are not meeting objectives. Contribute to developing then implement a standardized system for the technical and ethical review of all company sponsored clinical research projects. (year end) Provide clinical expertise to regulated product development projects and to all aspects of clinical research efforts as a member of core teams. (engage within 90 days) Assist in defining standardized clinical strategies and process for development projects. (6 months) Responsible for the development and management of clinical studies that support the successful commercialization of new and existing products Manages multiple, concurrent clinical studies through external clinical research organizations (cross) and internal Project Managers and Clinical Research Associates (CRAs) Assists in the development of clinical trial strategies for a number of projects Participates in marketing strategy development with Product Management and provides scientific support for therapeutic area products.Basic Qualifications:- Requires a minimum of a BS in a relevant field- Requires a minimum of 5 years' pharmaceutical / device industry experience that includes a minimum of 4 years' direct clinical research/development engagement.Preferred Qualifications:Experience in the following areas is desired:- Development and design of study protocols and all related documentation- Determination of clinical supply requirements- Supervision of individuals and CROs, training, and evaluation of associates in monitoring study sites- Coordinate compilation and analysis of outcomes data across all protocols in a given project, and in preparation of clinical summaries for submission to the FDA and other regulatory authorities. - Strong preference for BOTH Pharma(INDs, Phase I-IV studies and studies that have led to NDAs application and/or approvals (requirement) and device(IDEs and studies that have led to PMAs and/or PMA supplement application and/or approvals) (preference) study experience. - Global clinical trial experience preferred.Other Qualifications:- Experience with the participation in cross-functional teams - Demonstrated success in managing direct reports, which led to product submissions.Apply online at and enter Requisition ID#4116 Equal opportunity employer

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Minimum Education Required: BachelorYears of Experience Required: More than 5 yearsExpected Travel Time: NoneThis company may offer relocation assistance.