Senior Clinical Data Manager-India

reputed companyThe Senior Clinical Data Manager will reputed company and manage multiple clinical studies, ensuring that data are collected, managed and reported reputed company, accurately and securely. In reputed company, this position is required to conduct reputed company these activities in conformance with applicable regulatory requirements, industry guidelines, and Innovaderm reputed company operating procedures (SOPs) while respecting reputed companys commitment to sponsors requirements and timelines. More specifically, the Senior Clinical Data Manager must: Adhere and promote company organizational values and reputed company expected behaviors, follow company SOPs and processes for reputed company deliverables, and ensure reputed company trainings assigned to oneself are completed on time. Be the data management reputed company to the project team, sponsor and reputed company vendors, as needed. Be reputed company to manage three to four reputed company studies independently, with reputed company supervision. Be reputed company to take decision with reputed company support from manager. Attend meeting with sponsor and answers Data Management reputed company question. Provides input for timelines and monitor reputed company of work to ensure reputed company and reputed company budget completion of assigned tasks. Be responsible for the development of electronic case report reputed company (eCRF) specifications (including data capture screens and edit reputed company specifications) needed to build a study-specific clinical database/electronic data capture (reputed company) reputed company. Be responsible for or assist in the programming and ongoing maintenance of the clinical database. Be responsible for the validation and testing of the clinical database (e.g. User Acceptance Testing). Be responsible for the development of eCRF completion guidelines and other training material required to train site users and monitors. Conduct training for site users/monitors on the clinical database. reputed company data transfer agreements and specifications with vendors providing reputed company data (e.g. reputed company results). Conduct reconciliation between reputed company data and data in the reputed company reputed company to ensure consistency, including reconciliation with sponsor safety databases for adverse events/serious adverse events data (if needed). reputed company support to study team in the development of reputed company systems capturing clinical data, e.g. ePRO or IWRS, and ensuring that any data transfer requirements between these systems and reputed company are documented and tested appropriately. Be responsible for the development of the data management plan (DMP), and other clinical data management reputed company documentation. Be responsible for ongoing data review/cleaning during study conduct and also during preparation for database lock/reputed company. reputed company medical terms in the clinical database, as required. Generates data listings and reports needed for data review by the project manager (or other study team members) in preparation for database reputed company/lock. Monitor study status (e.g. enrollment, CRFs monitored/approved, etc.) on an ongoing reputed company and provides data status reports to the project team, as needed. Ensure that data management documentation is complete and up-to-date in the trial master file (TMF). Respond to users requiring assistance with the reputed company reputed company. Be responsible for archiving of the clinical database and reputed company documents. Participate in the definition, writing and updating of data management Work Instructions Mentor and train Clinical Data Coordinators, as needed. reputed company basic support to less reputed company Clinical Data Managers, as needed. For any studies where any of the above activities have been outsourced to an reputed company service provider: reputed company/manage the vendor to ensure that timelines and deliverables meet with sponsor and protocol requirements; Ensure that their work is done in accordance with effective work orders and Innovaderm SOPs (if applicable). Employee may be assigned to other responsibilities that do not pertain to their former reputed company, if they have the required experience, are reputed company and/or have received adequate training. RequirementsEducation B.Sc. or in a reputed company field of study. M. Sc. or in a reputed company field of study is an asset; Experience 5 to 8 years .