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A Clinical Operations Manager plays a crucial role in the planning, execution, and management of clinical trials. The responsibilities encompass various aspects of the clinical trial process to ensure that studies are conducted effectively, ethically, and in compliance with regulatory requirements. Here are some key tasks typically associated with the role of a Clinical Operations Manager and Cetacea Consulting can support you in all these tasks and many more:

1. Study Planning and Design

2. Clinical Research Organization (CRO) selection and Management
• Oversee performance
• Oversee the budget
• Perform sponsor oversight on delegated tasks
• Ensure they meet quality standards and timelines

3. Site Selection and Management
• Help you identify and select appropriate clinical trials sites and investigators
• Oversee the initiation, training and activation of study sites
• Oversight on Monitoring activities
• Manage relationship with investigators and site staff to ensure adherence to study protocols

4. Help develop the Electronic Data Capture (EDC) Database by:
• Reviewing what data should be captured and when
• Developing edit and logical tests
• Performing user acceptance tests

5. Data management
• Work with data management teams to establish data collection and monitoring processes
• Oversee data quality and integrity throughout the study

6. Developing study documents, such as:
• Informed Consent documents
• Monitoring Plan
• Cohort Management Plan
• Communication Plan

7. Set up and maintain a Risk Management Plan
• Identify potential risks and challenges in the study and develop strategies to mitigate them
• Implement risk management plans to address issues that may impact the successful execution of the clinical trial

8. Support Regulatory Compliance
• Ensure that the clinical trial complies with all relevant regulatory requirements and guidelines
• Carefully plans the submission strategy

9. Budget and Resource Management
• Develop and manage the clinical trial budget, ensuring financial resources are allocated appropriately.
• Monitor expenses and ensure adherence to financial plans

10. Vendor selection and management
• Oversee performance
• Oversee the budget
• Ensure they meet quality standards and timelines

11. Investigational Medicinal Product (IMP) Management
• Help create the IMP label
• Monitors of shelf life
• Lead re-labelling campaigns
• Monitors availability of IMP at depots and sites

12. Set up Study Logistic
• Lab Sample Management
• Organize and oversight of IMP shipment

13. Central Lab Set up and Oversight

14. Protocol Amendments and Compliance
• Manage any changes to the study protocol, ensuring proper documentation and regulatory approvals.
• Monitors and enforce compliance with the approved protocol
• Manage Protocol Deviation and reporting

15. Communication and Reporting
• Facilitate communication among internal and external stakeholders, including investigators, sponsors, CROs, regulatory authorities, etc.
• Prepares regular status reports and updates for senior management and other relevant parties

16. Clinical Trial monitoring
• Implement and manage monitoring plans to ensure data quality and site adherence to protocols.
• Oversees monitoring activities conducted by clinical research associates (CRAs)
• Oversees and develops patient recruitment and retention strategies

17. Electronic Trial Master File (eTMF) Management
• Develop an eTMF filing plan
• Oversight of completeness of the eTMF
• Oversight on quality of the eTMF
• Inspection readiness of the eTMF

18. Study Close out activities
• Database cleaning
• Database lock
• Data analysis oversight
• Clinical study Report development oversight
• Archiving of the clinical trial

19. Safety management
• Oversight of safety reporting

20. Quality Management System
• Support in building a clinical quality management system
• SOP writing