Clinical Data Manager
Lead Clinical Data Manager with a demonstrated history of working in the pharmaceutical industry (Merck MSD Oncology trials). Organized and disciplined person who have ability to work independently within and leading big teams, skilled managing Oncology trials during FDA submissions, start up and in life protocols. Trainer of CRAs, study coordinators and Mentor of new hires (junior CDMs).
Strong research professional with a masters degree focused in Medical Diagnostic Imaging, lead of the Oncology imaging SME (Subject Matter Expert) and quality review teams. Excellent communication with Sponsor and customer.
Experience in Electronic data capture (InForm, COGNOS and Jreview)
Skilled in start-up studies (study design, eCRFs development, DM specs building)
Experience in protocol data review including SAE reconciliation (data reconciliation- Data integrity)
Ability in Query management and Data management spec maintenance
Knowledge in internal and external laboratories.
Excellent communication skills (coordinate and provide support to protocol groups (Clinical, Biostatistical, TM, vendor´s customer ))
Applicable knowledge related to GCP/ICH and GCDMP.
Outstanding eTMF documentation management
Deep knowledge of medical terminology.
Knowledge of Standard global medical coding system MedDRA
Excellent Microsoft office management (Excel, Word)
Skilled performing user acceptance testing UAT and data validation process
Involvement as project manager
Effective problem solver.
High level of motivation to take initiative to improve processes.
Proficient at working with cross-functional teams to ensure functionality of clinical databases
grow up as a professional learning from the best, a challenging job with good benefits, good professional and personal enviroment, a company that offer visa sponsorship, since I´m From Colombia and I would like grow in a huge research field
Work in United States
Expected Base Salary
Total Professional Experience
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