Senior Lead Clinical Data Manager

  • IDDI
  • Raleigh, NC 27615, United States
  • Oct 30, 2017
Full time Admin-Clerical Information Technology Professional Services Skilled Labor

Job Description

In the position of Senior Lead Clinical Data Manager, you will be in charge of all aspects of the Clinical Data Management process for important projects.

Your responsibilities will be to:

  • Ensure that all CDM deliverables for the study including the SAS database are delivered on time with the expected quality.
  • Communicate with the sponsor and other collaborators of the project regarding data management issues.
  • Produce and maintain study related key Data Management documentation.
  • Ensure the CRF meets the data collection requirements of the study through review of the protocol and other supporting documentation.
  • Define and review edit-checks included in the Data Validation Plan as agreed with the sponsor.
  • Insure external data (Labs, SAEs, etc…) are transferred and reconciled with the clinical database.
  • Perform database unblinding and lock activities in close collaboration with the sponsor, Project Manager, statistician and other parties.
  • Develop the Data Management standards (templates and processes).

Your Profile:

  • A University degree, preferably in science
  • A minimum of 5 years of successful Clinical Data Management experience
  • SAS programming knowledge
  • CDISC standards knowledge is beneficial for the position
  • Fluent in English
  • Good planning and analytical skills
  • Excellent communication skills
  • Resistant to stress

We offer a permanent position in an innovative and dynamic company.