eClinical Project Leader - II

Covance ,
Alnwick, Northumberland
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Job Overview: Our Company: Joining Covance Flexible Solutions (FSPx) will offer a rewarding career, a chance to work in an energetic & team oriented workplace, and access to competitive benefits. With the support of exceptional people from across the globe and a vast array of career options, you'll be empowered to own your career journey with mentoring, training and personalized development planning. Our unique opportunity will allow you to bring your specialized discipline to a core team outsourced to a world class leading global healthcare company. Dedicated to our Client 100% of the time, you will play a key role in the drug development cycle and see a product through to launch with the support of both a dedicated Covance line manager and our client project teams. Your role: The EDC RAVE Programmer role is a great opportunity to work within our sponsor dedicated department and have this unique relationship with a sponsor. * Communicate effectively with the Project team in order to meet/exceed sponsor requirements. Take action where required in order to meet the timelines and deliverables. * Work with the study teams and management advising and informing on the processes that have to be completed to enable the technology to be implemented. Encourage interest and build confidence in the systems. * Advise management regularly on the status and any potential risks or issues with on-going projects to ensure resolutions in a timely manner. * Configure and build User and Site Administration modules to include site set up and assignment of roles, permissions and eLearning requirements. * Configure and build EDC standards in support of clinical studies including, but not limited to, Global Library, Edit Checks, Custom Functions, CRF modules and Standard/Custom Reports. * Setting up studies (eCRFs) using Medidata Rave application and using Oracle Clinical global library as a reference during the entire study build. * Validates specification to development through leading team review, co-programmer review, and User Acceptance Testing. * Setting up Targeted Source Data Verification (TSDV) configuration of the clinical trial database. * Maintain all required study documentation. * Support development and review of SOPs, and Work Guidelines to promote consistency. * Identify additional opportunities for standardization and departmental efficiency. * Perform other duties as required by the department Education/Qualifications: * Minimum 2 -- 4 years of experience; or an equivalent combination of education and experience to successfully perform the key responsibilities of the job * Experience in a clinical development environment * Experience in, or knowledge and understanding of, Medidata Rave, including database build and custom function programming Experience: * Peferred experience: * Implementation of industry standards; CDISC-SDTM/CDASH for a Standard Global Library set-up in Medidata RAVE. Employment Type: Full Time

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