Remote Operations Senior Manager

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Fri, Oct 16, 2020

This job expires in 17 days

Job Category: Business Operations, Healthcare, Quality Assurance, Research

Remote Level: 100% Remote

Weekly Hours: Full Time

Employment Status: Permanent

Employer Type: Employer

Career Level: Experienced

Education Level: Some College

Job Summary

a drug development company and clinical research organization is searching for a person to fill their position for a Remote Operations Senior Manager.

Candidates will be responsible for the following:

  • Processing, maintaining and archiving all essential documents in compliance with the relevant Standard Operating Procedures (SOPs), country regulations and industry best practice
  • Assisting to guide the strategy and leading the delivery of department objectives in ensuring the management of the essential documents
  • Fulfilling the "Trial Master File (TMF) Approver" and/or "TMF QC Reviewer" roles as defined by the relevant SOPs, as well as performing the role of the "TMF Process Owner"

Skills and Requirements Include:

  • Combination of education plus 8-11 years of relevant experience
  • In depth knowledge of ICH GCP
  • Experience supporting GCP inspections (e.g., FDA, PMDA, EMA, Bfarm, MHRA, etc.)
  • Experience of Document Management and/or eTMF solutions (e.g. Veeva, Trial Interactive, Documentum, etc.)
  • Ability to provide compliance and quality oversight of TMF processes
  • Ability to influence key personnel via a matrix organization