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Regulatory Affairs Manager in Clinical Research
2 months ago
DocTrials is in search of a skilled Clinical Research Regulatory Manager. This role is ideal for individuals who have a strong commitment to regulatory adherence, effective task management, and the maintenance of excellence in clinical research. As a vital contributor to our organization, you will be responsible for supervising various regulatory functions and ensuring that all procedures comply with industry standards.
Core Responsibilities:
- Lead the organization-wide Regulatory Compliance initiatives
- Oversee tasks within the Regulatory Department
- Facilitate Credentialing Processes
- Manage Calibration & Certification activities
- Direct Study Start-Up Procedures
- Perform Internal Monitoring & Mock Audits
- Administer Audit Management processes
- Develop & Maintain Standard Operating Procedures (SOPs)
- Evaluate & Sanction Protocol Deviations
- Foster Sponsor/CRO Relationships
- Coordinate Study Meetings
- Supervise Monitor Visits
- Manage Study Close-Out Procedures
Required Qualifications:
- Expertise in Clinical Trial Management Systems (CTMS) and related clinical 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
What We Provide:
- Attractive Salary Package
- Comprehensive Benefits
- Paid Time Off
- Incentive Structure
- Opportunities for Professional Growth
- Collaborative Work Environment
About DocTrials:
At DocTrials, we are dedicated to executing high-quality clinical studies across a network of physician sites. Our mission is to connect patients and healthcare providers with innovative therapies, offering hope and new treatment possibilities. Be part of our effort to make a significant impact in the healthcare sector.