Sr. Clinical Data Coordinator

Sr. Clinical Data Coordinator 
Tech Observer India Pvt Ltd. - Delhi, Delhi

Responsibilities: -Monitors project-specific and departmental document tracking and control activities. -Reviews CRF (as per protocol) and project-specific documents prepared by Clinical Data Coordinator(s)/ Clinical Data Associate(s). -Responsible for allocating responsibility of maintaining project-specific DMTMF (Data Management Trial Master File) and e-filing within the team and reviewing it on an ongoing basis. -Handling requests/issues by the client and team, in coordination with PM. -Guides CDCs/ CDAs in User Acceptance Testing (UAT) leading to robust database design. -Guides CDCs in procedure verification as a part of database validation. -Responsible for creating, reviewing, processing and tracking of Data Clarification Forms and updating clinical databases for ensuring data validity as per the protocol. -SAE Reconciliation and Medical Coding activities based on project requirements. -Reviews manual data listings as needed. -Ensures that the documents are in place for Pre-production and Pre-lock audits. -Assists in database lock/ freeze process & final data transfer activities. -Conducts project and process specific training for subordinates. -Acting as a back-up for Assistant Project Manager and supporting role for Clinical Data Manager. -Assists in preparation/ review of departmental SOPs. -Conducts advanced QC functions for departmental activities. -Ensures SOP compliance in project deliverables. For more info visit at mentioned link