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Senior Manager of Clinical Data Management

Company: Leica Biosystems
Location: Miami
Posted on: December 5, 2019

Job Description:

Senior Manager of Clinical Data Management North America-North America-United States-FL-Miami Senior Manager of Clinical Data Management will be responsible for the technical and administrative data management function for Clinical Affairs. This position is responsible for leveraging the Danaher Business System and tools in the timely and high-quality execution of a clinical data management strategy for pre-market and post-market clinical programs sponsored by the Beckman Coulter operating company: * Oversees internal and external clinical department infrastructure and staffing for assigned clinical programs with focus on data management strategy for research and development projects that establish conditions essential for determining safety, efficacy and marketability of biological or medical device data. * Responsible for assigned data management activities required for the planning /execution / reporting /closeout of clinical trials, ensuring that applicable policies, procedures and regulatory standards such as Good Clinical Practice are followed. * Leverages industry standards and best practices in clinical data management and establishes common systems/processes/tools that compliantly manage/store/output data in tabular/graphical formats amenable to assessing trial progress, reporting compliance status, trend analysis and statistical inference. * Maintains and/or establishes Standard Operating Procedures (SOPs) and a measurable process to build knowledge and ensure compliance with all applicable company policies, procedures and regulatory standards with respect to clinical data management processes. Drives continuous process improvement. * Accountable for costs, methods and associates as defined by company policies and procedures. Cultivates a positive work environment that reflects company values, embraces collaboration across functions and businesses, and promotes associate development. Duties & Responsibilities: * Provide Clinical data management support to clinical team, study projects, and biostatistics team. * Develop the data management plan for a clinical study. * Execute the data management plan throughout lifecycle of the study. * Participate in developing the case report form (CRF). * Develop database clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations. * Lead EDC database specification process. * Develop data transfer agreement(s) between external data sources and/or labs. * Reconcile electronic data transfers. * Assist in database upgrades/migrations including performing user acceptance testing * Maintain/track of EDC user management and other clinical databases across allocated clinical trials, compile master user lists and activate/deactivate user accounts. * Perform training on study trial for EDC and create user guides. * Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit. * Perform database lock and freeze activities. * Coordinate the archiving of study databases and related documents. * Perform close-out audits * Collaborate with IT and implementation team(s) to address clinical application requests and/or changes to clinical database systems. * Ensures data system compliance by following the established guidelines of regulatory authorities. * Bachelor's or Master's degree in technical or health care area with 7 9+ years of experience in developing and executing clinical data management procedures and thorough knowledge of clinical research. * Continuing education in clinical trial designs and monitoring procedures, FDA regulations and clinical data processing and reporting. * Working knowledge of GCP, FDA, ICH, CDISC, etc., regulations and guidelines * Knowledge and experience with Medidata and CTMS * Constructive interaction with inter and intradepartmental team members and personnel. * Good organizational skills, problem-solving abilities, time management skills and initiative. * Flexibility and ability to work on several assignments simultaneously. Must be able to work independently as well as part of a team. * Good written and oral communications skills in the English language. * Travel (domestic and international) up to 30% to other business locations, vendors or customers. Diversity & Inclusion At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. Science Full-time

Keywords: Leica Biosystems, Miami , Senior Manager of Clinical Data Management, Executive , Miami, Florida

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