Clinical Database Designer (Pune)

Job Summary Our global activities are growing rapidly and we are currently seeking a full-time office-based Clinical Database Designer to join our Biometrics team This position will work in a team to accomplish tasks and projects that are instrumental to the company s success If you want an exciting career where you use your previous expertise and can develop and grow your career even further then this is the chance for you Responsibilities Maintain eCRF and Edit Check Specification standard templates according to CDISC standards for data collection and data submission Develop and maintain eCRF specifications on a study-by-study basis e g reviewing protocol and customize library eCRFs to apply for the study from database build through database lock including Change Requests Develop and maintain Edit Check Specifications from database build through database lock including Change Requests to ensure that all data collected are present logical and per expected protocol assessment schedule and completion guidelines Perform validation of both the eCRF and the edits per the specifications ensuring that all possible entry scenarios are tested and documented Accountable for providing reliable and concise feedback to clinical data programmer Liaise and educate the Data Manager and Sponsor to ensure that eCRFs are well understood and the EDC database is set up per Sponsor expectations e g attend ongoing meetings with the Sponsor during setup of study Liaise with Clinical Db Programmer to ensure that eCRF and Edit Check Specifications are clearly defined and can be accomplished in the referenced system Design and develop customized project-level reports that are useful to the team via the reporting tools within the EDC systems e g Business Objects JReview Lead eCRF specification review meetings with internal project team to discuss eCRF specifications and Lead eCRF specification review meetings with external project team to discuss eCRF specifications and speak knowledgeab .