Senior Centralized

Key Responsibilities

Standard Operating Procedures

• Adhere to all applicable Standard Operating Procedures (SOPs) and Work Instructions relevant to departmental and study-specific activities.

Daily Operations

• Perform day-to-day operational tasks, ensuring adherence to quality standards and maintaining productivity levels.

Metrics Tracking

• Track and report metrics as defined by management within required timelines.

Process Improvement

• Participate in process improvement initiatives, assisting with the implementation of revised processes and procedures to enhance efficiency and compliance.

Study Management Support

• Manage clinical systems and oversee access management for study tools and platforms.
• Handle and maintain study documents, supporting electronic Trial Master File (eTMF) management.
• Maintain and update study databases (e.g., CTMS, IWRS, EDC).
• Assist the study team with data review and other support activities.
• Track and follow up with Clinical Research Associates (CRAs) regarding outstanding issues.
• Generate study-specific reports to support decision-making and monitoring.
• Manage internal and external communications to ensure alignment among stakeholders.
• Ensure training compliance for all study team members.
• Oversee study payments for clinical sites and vendors, ensuring accuracy and timeliness.