Clinical Data Management Specialist

Clinical Data Management Specialist #clinicalresearch #clinicaltrials #clinicaldataanalyst #REGULATORYaffairs #medicalcoding #medicalbilling #research #healthcare #medicalresearch #clinicaltrial #science #clinical #health #clinicalstudies #pharma #medical #pharmacy #biotech #clinicareers #pharmacovigilance #pharmaceuticals #clinicalstudy #pharmacovigilance #medicalaffairs #clinicalresearchassociate #pharmaindustry #doctor #phd #oncology #drugdevelopment #cra #biotechnology # Clinical Data Management Professionals. Education- B. Sc./ M. Sc./ B. Pharm/ M. Pharm/ MCA/ B. Tech Experience - 3 to 6 years for Data Manager & 7 to 15 years for Lead Data Manager Job Role for LDM: Location - Mumbai/ Bangalore Project Management, Client Management, Stakeholder Management Experience in managing data management deliverables. Creation/ Review of the study documents like eCRF Layout, DVR specification, Review of eCCG, DMP, and Data transfer plan. Responsible for data flow, discrepancy Management, and all other data management-related processes. Handling third-party data reconciliation activities & Database Lock Activities. Responsible for attaining all requirements from the client for quality deliverable Creation/ Review of the study documents like eCRF Layout, DVR specification, Review of eCCG, DMP, and Data transfer plan. Job Role for DM: Location - Mumbai 1. Understanding of Protocol and study documentation. Hands-on experience working on setup activities, third party and SAE reconciliation, discrepancy management, and database lock. Supporting Lead data manager in developing study metrics and study status reporting. Well verse in Writing eCRF specifications, Preparation of Protocol Deviation Document., Drafting eCRF completion guidelines.,Writing DVR specifications and writing Test step, Creation of UAT plan, performing UAT. Preparing UAT report. Preparing Data Transfer Agreement for Vendor, Preparing and maintaining DMP Metrics. Coordinates with the LDM, TA Lead with respect to any unresolved queries and close the same.