Clinical Data Manager
Position Description & Responsibilities
The Clinical Data Manager (CDM) is 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 Vanda 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
Vanda Pharmaceuticals offers a competitive compensation package with excellent benefits and a 401(k) matching program. Vanda is an equal opportunity employer, committed to the hirin
g, advancement and fair treatment of individuals without regard to race, color, religion, sex, sexual preference, age, national origin, ethnicity, disability, or any other protected
status designated by law.
Applicants should submit a cover letter with their Curriculum Vitae or Resume to:
Reference #: I6009
Vanda Pharmaceuticals Inc.
2200 Pennsylvania Avenue NW, Suite 300E
Washington, DC 20037
"Please note that the duties and responsibilities within this role may change over the course of employment, which will require flexibility."
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