Clinical Data Manager

Location
San Diego, CA
Salary
Market competitive + bonus + stock options + all benefits paid + stock purchase plan
Posted
Apr 08, 2021
Required Education
Bachelors Degree
Position Type
Full time

Principal Duties and Responsibilities:

  • Review data and generate queries according to the data validation specification (DVS)
  • Maintain documentation relating to clinical data management including maintaining the data management portion of the Trial Master File
  • Write and maintain DVS
  • Interface with and train site personnel (globally), monitors (globally) and clinical operations staff to provide support related to data management, including but not limited to the following: EDC issue resolution, acquisition of outstanding data, assisting in visit reconciliation for site payment, and site closure
  • Develop trainings for online delivery
  • Assist in streamlining clinical data management procedures to create effective practices
  • Set up studies in EDC system
  • Write edit checks in in EDC software
  • Write data listings and simple reports in SQL or R or other languages (on the job training provided), participate in peer code review, validate code, and maintain code repositories
  • 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
  • Coordinate medical coding
  • Manage data from external vendors in compliance with 21 CFR Part 11
  • 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.