Job Title :Clinical Data Specialist Location :Boulder/Denver, Colorado Duration : 1-2 years or longer term contract Description Candidates must have experience leading all data management aspects. A candidate with clinical data manager experience is very helpful but the manager wants to be clear they will not be managing people in this role. Clinical Data Specialist -Provide input into Case Report Forms (CRF) design and approve CRFs for production use -Oversee the design and maintenance of Oracle Clinical databases -Validate of study databases, reports, components, etc. -Define edit-check procedures and validate new edit-check processes -Define and maintain components/interfaces -Identify data review processes and define specifications for data review tools; oversee data cleaning activities -Observe trends and track data quality -Lock/freeze databases -Must have excellent verbal and written communication skills -Must have project management skills -Data management/clinical research experience preferred ______________________________________________________________________ POSITION DESCRIPTION: As a member of Company Clinical Operations (MCO) Data Management, this position is responsible for ongoing support for data management activities which assure quality of data delivery. This position: interacts with internal data management (Clinical IT Development and Statistical Programmers) colleagues and MCO partners and possibly business partners including clincial study teams, Global IT, business strategists, and statisticians for the purpose of data management, system development, and data cleaning activities across multiple trials. supports or executes the development of data management tools, data quality, and data review activities. may lead data management processes for low to medium complex studies (with oversight or mentoring) may support and/or work with additional project teams, disciplines, or functions within Company. Position responsibilities: Supports all aspects of Data Management, including: o creation of Case Report Form (CRF) specification and design and the specification of Edit Check requirements. o supporting and/or executing the validation and testing procedures of clinical database, eCRF and edit checks (eg, Functional and User Acceptance Tests) which may include writing test scripts. o data entry and data reporting. o data review and discrepancy management in accordance with Data Management Plan and Data Review Guidelines. o defining data review requirements and processes to ensure delivery of highest quality of data. Ensures timely and successful execution of the assigned data management tasks. Participates in project meetings to provide status updates to stakeholders. Provides communication of risk and mitigation for all data management related deliverables. Assists in overall project tasks such as process flowcharts, Standard Operating Procedures (SOPs), work instructions, training guidelines, etc. Assists in FDA and Quality audits that involve data management. Supports the creation and maintenance of all essential data mangement documentation such as CRFs and annotated CRFs, Data Management Plans, Data Review Guidelines, CRF Completion Guidelines, Data Entry Guidelines, testing plans, and other study specific work instructions or guidelines for assigned projects to ensure compliance to quality system. Remains current on data management technology, processes, and best practices via reading, formal course work, membership in professional organizations, etc. Follows and implements data management standards and best practices and assures Standard Operating Procedures compliance (eg, use of standardized Case Report Forms, univariate versus multivariate edit checks, reusable edit check specifications). Monitors key performance indicators and takes appropriate action based on results. Bachelors degree Years of experience: 2-4 years experience (0-2 years of experience with Masters) Specialized Knowledge Required Clinical database systems knowledge: intermediate to advanced level proficiency with relational databases (EDC) systems. Big-picture and detail-oriented view of data management processes, tools and procedures. Desired/Preferred Qualifications (optional) (documented by either experience or certifications) A good understanding of the clinical research life cycle process, knowledge in medical device and/or pharmaceutical data management environment. Key Technical Competencies: Clinical database systems knowledge electronic data capture (EDC) and paper. Intermediate level of proficiency with relational databases in either paper or EDC, understanding of data management processes, tools, and procedures. Analytical Skills: Intermediate proficiency in Case Report Form design, adhoc data reporting, data review listing development, metrics reporting, distribution, and review. Beginning understanding of key analytical end point needs. Developing ability to analyze clinical protocol requirements and translating them into data management requirements. Solid understanding of clinical terminology, regulations, GCP, GDP, GDMP, FDA 21 CFR Part 11 regulation, ICH, and HIPAA. Intermediate skills and knowledge in adhoc data reporting, creating data review listings, metrics reporting. Candidates are required to design CRFs and edit check specifications. Ability to manage multiple priorities by applying time & task management approach. Computer proficiency in MS Office products (eg, Microsoft Project, Excel, MS Word). Preferred experience in Oracle Clincial, CRF design tools, and reporting tools (eg, TOAD, Business Objects, Spotfire). Associated topics: aseptic, disease, histologist, histology, histotechnologist, microbiology, nephrology, nutrition, physiology, therapeutic
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