Job description
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
Position Requirements
- 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
Education
Required- Bachelors or better
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
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