Clinical Data Manager

Location
94520, Concord
Posted
Apr 13, 2018
Required Education
Bachelors Degree
Position Type
Full time

Responsible for providing quality management of clinical trial data in a rapidly-evolving environment.

Primary Responsibilities:

  • Lead data management activities including Case Report Form (CRF) designing, database designing, developing Data Management Plan, CRF annotation, implementing edit check programs, data entry and query status tracking, and database closure.
  • Track important study metrics on data entry, source verification, and query status, and presenting these metrics to a cross-functional team in weekly meetings.

Qualifications/Requirements/Skills: 

  •    Bachelor’s degree with a minimum of 2 years of Clinical Data Management experience at a pharmaceutical/biotechnology company or Contract Research Organization.
  • Experience leading the database lock of a clinical study preferred.
  • Computer literacy with competence in MS Word and Excel.
  • Understanding the principles of clinical research, GCP (Good Clinical Practice), and GCDMP (Good Clinical Data Management Practices).
  • Logical thinking, attention to detail, good organizational skills, and problem-solving abilities.
  • Good communication and writing skills.
  • Ability to prioritize and to adapt quickly to changing business conditions plus a “can-do” attitude.
  • Working knowledge of SAS or SQL preferred.
  • Working experience with Excel associated with conditional formatting, complex formula, and macros a plus.

Excellent understanding of CDISC data models a plus.