Clinical Data Associate Ii

Clinical Data Associate II Statistics Data Corporation SDC a specialized contract research organization CRO headquartered in Arizona delivering top-tier clinical trial services to pharmaceutical biologic and medical device diagnostic companies since 2005 SDC providing a technology enabled service offering to provide clients with both clinical services expertise as well as the technology they need to be successful in their clinical trials Job Summary Performs data management activities in support of clinical research studies that includes review of clinical data external vendor supplied clinical data laboratory data serious adverse event data unexpected adverse device events query management identification generation resolution review and close-out Primary Responsibilities Track and maintain audit-ready clinical study documentation in support of data and listing reviews within the electronic and or hard copy Trial Master Files for multiple projects Perform data entry and query management including data listing review query creation and resolution Perform study related activities within budgeted time Work with QC and QA teams to make the internal TMF ready for study deliverables in regard to data review reconciliation and listing documentation Perform study conduct activities including but not limited to Query Management Listing Review Perform 3rd party reconciliation and SAE reconciliation as assigned Adhere to all aspects of SDC s quality system Comply with SDC s data integrity business ethics requirements Perform other duties as assigned Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements The above statements describe the general nature and level of work being performed by individuals assigned to this classification This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified Requirements Required Skills Basic proficiency with Microsoft Word and Excel software Ability to work well in a team environment Excellent organizational skills and attention to detail Ability to successfully work on multiple projects and prioritize daily tasks and responsibilities Effective communications skills both written and verbal Possess strong problem-solving skills be solution-oriented Additional desired skills might include any of the following medical terminology familiarity with relational databases electronic data capture systems clinical research coordinator experience working knowledge of clinical trials and Data Management s role in the clinical trials process Education or Equivalent Experience Bachelor s degree preferably in applied or life science and at least 3 years work experience Benefits Why SDC SDC is a team of diversified professionals who deliver exceptional Biometric Services Consulting and Technology Solutions to pharmaceutical biologic and medical device diagnostic companies Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results We are a specialty CRO in that we provide scalable service offerings focused services area specialists efficient project timelines optimal technology solutions and proven success and experience Our commitment to our clients is the same commitment to our employees By offering strong benefits including competitive pay generous time off attainable career advances and positive work life balance we are able to attract some of the most talented people in the industry We are committed to developing our employees We recognize achievements provide growth opportunities and career advancement offer a flexible work schedule engaging work culture and employee benefits We are passionate about our company culture Our recognition program is directly tied to our core values of Energy Integrity Engagement Innovation Ownership and Commitment We strive to provide a place of belonging to our employees with fun and engaging activities from SDC s culture club We are constantly growing and innovating to support our client and employee needs Global in nature we bring diverse perspectives enabling our growth in this ever-evolving industry With a proven track record SDC has been successfully executing client clinical programs since 2005 Take a look at how you can join our team LI-Hybrid