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Job Details

Clinical Study Manager

Company name
Smith & Nephew.

Location
Fort Worth, TX

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Description ABOUT US Smith & Nephew supports healthcare professionals in\u00a0more than 100 countriesin their daily efforts to improve the lives of their patients. We do this by taking a\u00a0pioneering approachto the design of our\u00a0advanced medical products and services, by securing wider access to our diverse technologies for more customers globally, and by enabling better outcomes for patients and healthcare systems. We have leadership positions in: Orthopaedics Reconstruction - joint replacement systems for knees, hips and shoulders Advanced Wound Management - wound care treatment and prevention products used to treat hard-to-heal wounds Sports Medicine - minimally invasive surgery of the joint Trauma & Extremities - products that help repair broken bones We have around\u00a015,000 employeesaround the world. Annual sales in 2016 were more than $4.6 billion. We are a constituent of the UK's FTSE100 and our shares are\u00a0traded on the London Stock Exchangeand through\u00a0American Depository Receipts on the New York Stock Exchange(LSE: SN, NYSE: SNN) SUMMARY Conduct clinical studies to support regulatory submissions and post market surveillance of Smith & Nephew products. Conduct observational studies. Ensure adherence to Good Clinical Practices and applicable regulations, standard operating procedures, Smith & Nephew Code of Conduct, and study protocols in accordance with established budgets and timelines. Essential Functions Assist in tasks related to protocol development of global clinical studies. Assist in training investigators, research coordinators, Contract Research Organizations (CROs), central laboratories, and other study vendors on study related procedures. Assist in providing first tier support for protocol, SOPs, and systems. Assist in planning, managing and reporting all aspects of one or more global clinical studies by working with study management team to oversee cross-functional study activities. Assist in creating and reporting clinical study updates to management on a regular basis; report on performance to plan. Work with study management team to coordinate and oversee clinical studies to support regulatory submissions (IDE, PMA, 510 (k) and Post Market Surveillance); assist in preparation of clinical study reports, regulatory documents and submissions as directed. Work with Study Management to liaise with ASD product teams and in country sales and marketing personnel to ensure effective study alignment with product strategy throughout the design, implementation and lifetime of the clinical study. Assist with monitoring, and\/or assist CRAs with monitoring activities, to ensure compliance with study protocols, regulatory requirements, and Smith & Nephew procedures. Follow current SOPs. May make recommendations to management for improvements. Assist with organizing and leading internal and external meetings with associated communications and materials. Assist in compiling information for scientific publications in international peer-reviewed journals and other publications, conferences, and other media as appropriate. Qualifications Requirements Travel-Domestic International - Up to 25% Education Bachelor's degree in life sciences or related area; or combination of education and experience. Licenses\/Certifications Willingness to work toward CCRP or CCRA certification desired. Experience Minimum 0-2 years' experience in medical device industry, clinical setting or research field. Competencies (1) Ability to follow oral and written instruction (2) Ability to research potential investigational sites and investigators (3) Professional communication skills - strong oral and written English (4) Attention to detail. Supervision Requires day to day supervision and oversight. Other (1) Experience with Microsoft Excel, Word, and PowerPoint.

Company info

Smith & Nephew.
Website : http://www.smith-nephew.com

Company Profile
The Group has a history dating back 160 years to the family enterprise of Thomas James Smith who opened a small pharmacy in Hull, England in 1856. On his death in 1896, his nephew Horatio Nelson Smith took over the management of the business.A few days after the declaration of World War 1 in 1914, Horatio Nelson Smith (the nephew of the company founder T. J Smith) met with an envoy of the French President in London. The company was awarded a contract to supply £350,000 of surgical and field dressings, to be delivered in five months. By the late 1990s, Smith & Nephew had expanded into being a diverse healthcare conglomerate with operations across the globe, including various medical devices, personal care products and traditional and pioneering woundcare treatments. In 1998, Smith & Nephew announced a major restructuring to focus management attention and investment on three business units — wound management, endoscopy and orthopaedics— which offered high growth and margin opportunities.

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