Goal-oriented professional with 8+ years of experience as a Clinical Data Manager adept at managing databases with strong leadership and relationship-building skills. Highly skilled in reasoning and problem solving and can work as an individual and as a part of a team. An ingenious, positive approach to work, with the ability to bring quick, innovative resolution to challenges. Outstanding ability to plan, analyze and accomplish the CDM objective in a timely manner. Strong and comprehensive CDM skills spanning from study startup, study conduct, and closeout activities. Proficient in e-CRF design specification, Edit check creation, data cleaning, and query process, SAE reconciliation, and lab data reconciliation. Efficient experience in managing CRO’s work, study start-up, study conduct, and study close- out activities of clinical trials to deliver clean and quality data. Excellent experience in the study setup and smooth study conduct, close-out, reviewing the performance, protocol deviation, and maintaining awareness of issues raised. Developed Case Report Forms (CRFs), Data management plans (DMPs), and User Acceptance testing (UAT) for multiple clinical projects in accordance with protocol specifications. Worked on study conduct activities like Data Validation, Discrepancy management, SAE reconciliation, and Lab reconciliation. Expertise in CRF tracking, database QC and database audit. Therapeutic experience in cardiovascular disease, respiratory disease, and Oncology Expertise in working with vendor management, team management, and client interaction and communicating with various other departments within the clinical research domain.
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