Clinical Data Management Associate

Location
New York City, New York (US)
Salary
Around $70,000 USD
Posted
Oct 19, 2017
Closes
Dec 19, 2017
Contract Type
Full Time
Job Type
Staff Scientist

A breaking through Biopharmaceutical Company is looking for a Clinical Data Manager experienced with late phase FDA studies to be in charge of company’s clinical trial data and databases.

What you will do:

  • Be in charge of company’s studies database cleanup
  • Perform CRF design and reports design, edit checks writing, EDC SOPs writing
  • Work with statistics team to develop statistical plan based on CRF design and data management plan Involved in data management plan and data transfer plan writing
  • Review electronic CRF, generate and close queries
  • Communicate directly with medical monitor & pharmacovigilance department for resolution of site open safety issues
  • Communicate directly with site CRAs for resolution of site open issues
  • Generate ongoing data cleanup reports and distribute to participating sites Generate ongoing status reports

 

Your Experience and Qualifications

  • At least 3 years as a data manager in a big pharmaceutical company, with phase II/III FDA studies
  • Former CRA-  is an advantage
  • Conducted data management activities at all study stages- from CRF design to final data cleanup and study closure
  • Performed data management plan writing, relevant SOPs writing Independent worker
  • Proactive, knows to move processes forward
  • Efficient with good time management ability
  • Focused on and adherent with required study timelines
  • Details-oriented & organized person
  • Excellent inter-relationship skills
  • Excellent technical skills