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Regulatory Affairs Manager in Clinical Research

2 months ago

Phoenix, Arizona, United States DocTrials Full time
Position Summary

DocTrials is on the lookout for a skilled Clinical Research Regulatory Manager. This role is essential for ensuring adherence to regulatory standards, managing workflows efficiently, and upholding excellence in clinical research practices. As a pivotal member of our organization, you will supervise a variety of regulatory functions and guarantee that all operations comply with industry regulations.

Primary Responsibilities:

  • Oversee Company-wide Regulatory Compliance
  • Direct Regulatory Department Activities
  • Facilitate Credentialing Procedures
  • Manage Calibration & Certification Processes
  • Lead Study Initiation Protocols
  • Perform Internal Monitoring & Mock Audits
  • Administer Audit Oversight
  • Develop & Update Standard Operating Procedures (SOPs)
  • Evaluate & Sanction Protocol Deviations
  • Foster Relationships with Sponsors and CROs
  • Coordinate Study Meetings
  • Supervise Monitoring Visits
  • Manage Study Closure Activities

Required Qualifications:

  • Expertise in Clinical Trial Management Systems (CTMS) and related research tools
  • Excellent organizational and communication abilities
  • Knowledge of ICH-GCP and FDA regulations
  • Capability to handle multiple tasks and meet deadlines efficiently
  • Background in clinical research management

Benefits Offered:

  • Attractive Salary Package
  • Comprehensive Benefits Plan
  • Paid Leave
  • Incentive Structure
  • Opportunities for Professional Growth
  • Collaborative Work Environment

About DocTrials:

DocTrials is dedicated to executing high-quality clinical trials through a network of physician sites. Our mission is to link patients and healthcare providers with innovative therapies, providing hope and new treatment possibilities. Be part of our mission to enhance the healthcare landscape.