Clinical Data Manager

Location
La Jolla, California
Posted
Oct 23, 2017
Discipline
Clinical, Clinical Data
Required Education
Bachelors Degree
Position Type
Full time

General Summary:

The Clinical Data Manager is responsible for all data management tasks for multiple clinical studies from set up in electronic data management system (EDC) to database lock. Other responsibilities include:

Principal Duties and Responsibilities:

  • Review data and generate queries according to the data validation plan (DVP)
  • Maintain documentation relating to clinical data management including maintaining the data management portion of the Trial Master File
  • Write and maintain DVP
  • Interface with site personnel, monitors and clinical operations staff to provide support related to data management (including EDC system issue resolution)
  • Assist in streamlining clinical data management procedures to create effective practices
  • Set up studies in EDC system
  • Train monitors and site personnel on EDC system
  • Write edit checks in XML and data listings in SQL or R or other languages (on the job training provided)
  • Contribute to development of reports and plans (ie: clinical study reports/statistical analysis plans)
  • Coordinate with pharmacovigilance to review and generate queries related to serious adverse events
  • Correspond with and oversee data management vendors
  • Perform tasks according to company standard operating procedures (SOPs)

Qualifications:

Education

  • Bachelor’s degree or equivalent experience

Experience/Skills

  • Minimum of three years of direct clinical data management experience in the biotechnology or pharmaceutical industry
  • Working knowledge of Good Clinical Practices and ICH guidelines related to CDM
  • Exceptional organizational skills, highly adaptive in the face of changing priorities and practices
  • Effective written communication skills

Position Requirements:

  • May require limited travel for training purposes

NOTE: This description is not intended to be all inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job which may include other duties as assumed or assigned.