Tiempo Completo Clinical Data Manager
Descripción del empleo
Prulab Pharma Ltd. is seeking a Clinical Data Manager who will primarily be responsible for managing DM activities in the design, collection and lock of database for multiple phase I-IV clinical trials. As a member of the Biometrics group, the CDM will act as a member of clinical teams at Prulab Pharma and interface with external CROs and external vendors to fulfill many of his or her responsibilities.
Roles and responsibilities include the following:
*Serve as the Lead Data Manager on multiple studies
*Design and modify eCRFs and EDC edit checks
*Responsible for building, review and validation of clinical database
*Create and maintain project DM documentations
*Extract and monitor the trial data to identify issues
*Manage CDM activities in CRO and other vendors
*Mentor or train other junior members
Successful candidates will have the following background/experience:
*Minimum of BS preferably in Health Sciences, Statistics, MIS or Informatics
*Minimum of 3 experience in Clinical Data Management from CROs or Pharmaceutical companies
*Experience in electronic data capture (EDC) systems
*Knowledge of ICH/GCP guidelines and FDA regulations
*Knowledge of industry data standards (CDISC, SDTM, CDASH)
*Excellent organizational skills
*Outstanding interpersonal, oral and written communication skills.
Prulab Pharma offers employees a comprehensive benefits package that includes competitive salaries, comprehensive medical, dental and vision benefits, paid time off and volunteer hours, education assistance and much more.
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