Smith & Nephew.
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) \u00a0 SUMMARY Reporting to Director Global Biostatistics and Data Management, manages outsourced data management resource and processes from study development to database lock and regulatory submission support. Ensures clean and valid clinical study data for delivery to biostatistics. This position coordinates with data management programming, biostatistics, study management and site management to define and implement data management requirements. The job holder should be able to identify\/remove obstacles that impede meeting timelines and milestones. Essential Functions Plan and manage data management aspects of global clinical studies through management and oversight of outsourced data management staff. Responsible for outsourcing supplier contracts in line with the role. Create and report data management updates to management on a regular basis; report on performance to plan. Work alongside data management programming to ensure timely study start up and database availability. Facilitate data cleaning and manage timeline to database lock; interact with study sites and S&N site management as needed; responsible for database lock. Work alongside internal data managers, with the ability to deal effectively with internal and external customers; organize and lead internal and external meetings with associated communications and materials. Determine strategic direction for Case Report Form (CRF) standards. Review and approve applicable sections of regulatory submissions and contribute to regulatory submission strategy for clinical programs. Maintain knowledge of current technology, best practices and regulations in the data management space. Serve as part of Global Biostatistics and Data Management leadership team Qualifications Requirements Travel- None Education Bachelor's degree in a data related field, life sciences or related area; or equivalent combination of education and experience; advanced degree preferred. Experience > 10 years' experience in medical device industry, clinical setting or research field. Competencies (1) Data Management\/Project Management skills - demonstrates understanding and quality delivery of study\/data management milestones according to established timelines (2) Ability to handle complex projects (3) Knowledge of cross functional roles and responsibilities (4) Demonstrate strong problem solving and judgement skills (5) Demonstrate professional communication skills - strong oral and written English (6) Ability to create standard operating procedures (SOPs) (7) Advanced knowledge and application of industry standards and best practices in clinical data management and applicable country regulations (US FDA, ISO, ICH, CDISC) (8) Attention to detail (9) Product and indication\/disease knowledge, understanding basics of surgical procedures (10) Lead\/mentor\/coach data management staff (11) Effectively assign work to data management staff (12) Contract negotiation and approval (13) Implement strategic vision\/direction for overall clinical and data management technology infrastructure. Supervision and Reporting Structure Represents Global Biostatistics and Data Management team internally and externally. \u2022 Reports to the Director Global Biostatistics and Data Management. \u2022 Provides oversight and management of external data management vendor(s). Other (1) Proficient with Data Management Systems such as Datafax (Preferred), Oracle Clinical, Medidata, Inform (2) Proficient with electronic data capture (3) Proficient with Excel, Word, Powerpoint, Outlook, Sharepoint, Visio and Project
Smith & Nephew.
Website : http://www.smith-nephew.com
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.