Clinical Study Data Monitoring and Review

Clinical Study Data Monitoring and Review

Vacancy expired!

CLINICAL STUDY DATA MONITORING AND REVIEW
REMOTE
This is a fully remote position, even outside of COVID. We are looking for someone to perform data monitoring and review for device studies. The hours are flexible, as much of the work would be done outside of meetings.

Project Description:

• Support multiple clinical studies within the Device Therapeutic Area by assisting study teams with their data review activities to ensure a robust data package for registration.
• Work in conjunction with study teams to support study data review requirements.
• Tasks can include point-to-point checks of study data, e.g. verifying data (labs, assessments, etc.) to support study inclusion criteria, as well as interpretive analysis, e.g. evaluating subject data to find inconsistencies in the patient profile data.
• Responsible for performing activities that are in compliance with applicable Corporate and Divisional Policies, Standard Operating Procedures and Operating Guidelines and performing other duties as assigned by management.

Required Skills:

• Bachelor's degree or equivalent in one of the disciplines related to life sciences, drug development or business. (Less than a Bachelor's degree may be accepted if the person is an RN with relevant industry experience).
• Minimum of three (3) - four (4) years of clinical operations in pharmaceutical industry in order to have a thorough understanding of the processes associated with delivery of quality data.
• Broad business understanding of clinical development processes.
• Understand of regulation and guideline e.g. ICH, Google Cloud Platform.
• Experience in clinical data standards and terminology.
• Technically competent with Microsoft Excel.
• Possesses rudimentary knowledge of clinical study data management including case report form design, workings of electronic edit checks, implementation of data handling conventions and interpretation of data status reports.
• Able to work independently for periods of several days without much supervisory contact.
• Willing to work in a an independent/virtual setting where there is very little in-person contact.

This 6+month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget:

ALPHA'S REQUIREMENT #21-00703
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
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