Clinical Data Manager Job In Domnic Lewis Private Limited In Bengaluru / Bangalore

Job Responsibilities: Main point of client contact and study team for all DM related matters Execute all DM start-up activities, including the development and maintenance of oeCRFs and eCRF specifications oEdit check and custom listing specifications oCompletion Guidelines Participate to the design of the CRF Participate to programming of edit checks, validation and UAT Organize and actively participate in CRF review meetings with the client when needed Perform training on study trial for EDC and create user guides if needed Perform comprehensive hands-on data review of all subject data through query management and/or manual review Analyzes study metrics to continually assess both data quality and study progress Track and provide project status updates to project managers for monthly project team meetings Develop Data Transfer Agreements between external data vendors and/or core labs Reconcile electronic data transfers from vendor to vendor Manage and prioritize project deliverables per study timelines Reconcile SAEs when needed Work closely with CRA's to address any negative data trends/issues specifically ahead of site visits Moderate (blind) data review meeting with statistician and other required attendees including sponsor Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock Participate in the review and development of Quality documents (SOP and working practices) Archive study databases and related documents Qualifiaction/ Skills: Bachelor's degree required / Master's degree preferred Performs project specific task and duties with minimal guidance Follows established procedures 3 to 6 years relevant data management experience in the CRO/pharmaceutical industry required EDC experience required Applicable knowledge working with other clinical databases such as SAS Demonstrates knowledge of GCPs and protocol Strong comprehension and logic skills Strong time management and prioritization skills to meet deadlines among multiple projects Strong communication skills: verbal/written

Domnic Lewis Private Limited is looking for .

Domnic Lewis Private Limited is looking for Any Graduate / Post Graduate profile candidates.