Clinical Operations Department Responsibilities
1. Ensure Compliance with Regulations and Company SOPs
Ensure execution of clinical studies in adherence to regulations, GCP and SOP. In addition, ensure clinical trials are executed within compliance policy.
2. Management of Study Managers
Provide management for study managers including setting goals, performance assessment, and employees development to ensure that employees complete the corresponding onboard training and regular training in accordance with the departmental training schedule. Supervise subordinates to update and learn internal regulations or SOPs in a timely manner. Conduct new staff hiring, maintaining, and other management work.
3. Routine Personnel Management
Conduct routine personnel management work, review and approve the OA system.
4. Supervision and Guidance
Supervise and guide direct reports to communicate the encountered study problems with local/global or cross-functions. Help to identify potential risks and urge them to respond promptly to Daiichi Sankyos internal audits or external inspection. Resolve the controversial issues promptly.
5. Quality Control of Project Progress
Supervise quality control of project progress by the clinical operations manager. Take timely and effective measures to ensure study quality is not affected by personnel departure or long leave. Ensure study handover can be complete smoothly without quality affective.
6. Information Exchange among Members
Promote information exchange among members through various forms of meetings, including CO departmental regular meetings and section internal regular meetings and one on one meetings.
7. Insight for New Product Development in China
Provide insight from CO perspective for the strategy of new product development to be carried out in China.
8. Comprehensive Grasping and Supervision of Main Information
Be responsible for comprehensively grasping and supervising the main information at the research level, including the research period, budget, risk assessment, identification and communication of major stakeholders, etc.
9. Progress and Delivery of Global Clinical Trial Projects
As the representative of the Clinical Operations Department, accountable for the progress and delivery of global clinical trial projects. Supervise the trial execution process, including feasibility assessment, selecting and initiation of the research center, patients enrollment, data collection, and supervision of trial quality.
10. Supervision of Vendors
Supervise the screening, evaluation, and selection processes of vendors (CROs, SMOs, etc.) in China to ensure that all research-related activities conducted by vendors comply with required timeline, meet quality requirements, and Chinese regulations. Supervise and participate in the performance evaluation of vendors and provide feedback to the study teams.
11. Budget Management and Oversight
Assist in managing departments budget and oversight the budgets of various projects to ensure cost and benefit. Supervise the timely completion of clinical trials within the budget.
12. Clinical Operations Strategy and Annual Plan
Support CO head to generate department annual plans and goals, cascading the clarified operational goals, and optimizing and improving SOPs and processes related to clinical operations.
13. Support for Development Department Activities
Support the relevant activities of the Development Department of Daiichi Sankyos China. Coordinate the work of the clinical operation team with other cross-functions and related stakeholders to ensure efficient collaboration.
14. Communication and Cooperative Relationship Establishment
Connect with sites, vendors, DSCN, and global etc. Establish and enhance the communication, maintain good cooperative relationships with internal and external relevant stakeholders, and assist in resolving communication and cooperation issues.