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Job Details

Senior Clinical Study Manager

Company name
Smith & Nephew.

Location
Fort Worth, TX

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Profile

Description ABOUT US Smith& Nephew supports healthcare professionals in\u00a0more than 100 countriesin their daily efforts to improve the lives of theirpatients. We do this by taking a\u00a0pioneering approachto the design of our\u00a0advanced medical products and services, by securing wider accessto our diverse technologies for more customers globally, and by enabling betteroutcomes for patients and healthcare systems. Wehave leadership positions in: OrthopaedicsReconstruction - joint replacement systems for knees, hips and shoulders AdvancedWound Management - wound care treatment and prevention products used to treathard-to-heal wounds SportsMedicine - 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 $4.6billion. We are a constituent of the UK's FTSE100 and our shares are\u00a0traded on the London StockExchangeand through\u00a0American DepositoryReceipts on the New York Stock Exchange(LSE: SN, NYSE: SNN) SUMMARY Conduct clinical studiesto support regulatory submissions and post market surveillance of Smith &Nephew products. Conduct observational studies and ensure adherence of GoodClinical Practices, ISO 14155 and applicable regulations, standard operatingprocedures, S&N code of conduct and study protocols are in accordance withestablished budgets and timelines. Your responsibilities Independently assess study feasibility, collaborating with Clinical Strategy Lead through the study design process and collaborate with project team to develop clinical study protocols and associated documents Train investigators, research coordinators, CROs, central laboratories and other study vendors on study related procedures Plan, manage and report all aspects of global clinical studies through oversight of cross-functional study activities Create and report clinical study updates to management on a regular basis; report on performance to plan 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 Independently liaise with 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 Monitor and\/or oversee monitoring by CRAs, to ensure compliance with study protocols, regulatory requirements and Smith & Nephew procedures Follow current SOPs and evaluate current procedures for efficiencies and quality as well as make recommendations to management for improvement Organize and lead internal and external meetings with associated communications and materials Contribute to scientific publications in international peer-reviewed journal and other publications, conferences and other media as appropriate Supervise other clinical study managers and act as a deputy Qualifications Requirements Bachelor\u2019s degree in life sciences or related field or equivalent education and experience Minimum 5 years\u2019 experience in the medical device industry, clinical setting or research field with at least 3 years of managerial experience Demonstrate understanding and quality delivery of study milestones according to established timelines Ability to handle complex projects, prepare risk management plans and demonstrates problem solving skills Ability to identify investigational sites and investigators Advanced knowledge and application of industry standards and best practices in clinical data management and applicable country regulations (US FDA, ISO, ICH, etc.) Strong oral and written English and German skills, other languages are a plus Proficient with Clinical Trial Management Systems, Trial Master File Systems and Electronic Data Capture Ability to travel up to 25% We offer An Interesting and varied function in an international and interdisciplinary environment Modern infrastructure and opportunities to further advance your career The opportunity to play a relevant part in a medical network and to further develop a company with an excellent reputation Attractive compensation package and social benefits

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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