Prulab Pharma Ltd. is seeking a Clinical Data Manager who is responsible for managing I-IV clinical trials. As a member of the Biometrics group, the CDM will act as a member of Prulab Pharma and interface with external CROs and external vendors.
Roles and responsibilities include the following:
* Serve as the Lead Data Manager on multiple studies
* Design and modify eCRFs and EDC edit checks
* Extract and monitor the trial is 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 comprehensive insurance, dental assistance and much more.