Overview

Position: COVID-19 Clinical Trials Data Manager

Location: Bloomington, Minnesota

Duration: 2 Years – possiblity to convert long term

Onsite and Remote work

Job Description:

Our client is looking for a Sr Clinical Trials Data manager who can help with the management of data teams assigned to a COVID-19 vaccination specific clinical trial. This person will be assisting the Director and Critical Care Research ensure all data reporting and management is FDA compliant. They will be spearheading the work being done by this specific team. They will be working with clinicians and other healthcare professionals to make sure all adverse and serious adverse events are reported. This role will also help with the transition of paper CRF into electronic format.

Minimum Qualifications:

o Must have clinical expertise

o Strong knowledge of federal requirements for data reporting and management

o Adverse and serious Adverse event reporting

o Federal guidelines on the timing of reporting that data

o Previous experience managing clinical trials and data reporting

o Experience using Epic and smart phrases within the app

o Previously a monitor on large trials would be ideal

o Paper CRFs which will require someone to be onsite most days

o Also supervising Data Entry resources in person

o Experience setting up Federal compliant Clinical Trials

Preferred

o Experience with IRB Submission

o Experience with Regulatory Affairs

 Responsibilities:

o Managing the data from clinical trials COVID-19 Vaccine

o Managing data entry resources for clinical trial

o Ensuring all data reporting and data management is federally compliant with FDA regulations

o Report directly to the Director of Critical Care Research

Tracking

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