Senior Centralized

3 weeks ago

Bengaluru, Karnataka, India Thepharmadaily Full time
Job Description

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.

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