Risk Management Specialist

Remote EST - Based Risk Monitoring Consultant

• 12-month W2 contract

1. Assess and Optimize Risk-Based Monitoring Processes:

- Evaluate the existing risk-based monitoring processes and procedures within the organization.

- Identify areas for improvement and optimization, leveraging sponsor-side best practices.

- Collaborate with the internal teams to design and implement enhanced risk-based monitoring approaches.

2. CTMS Configuration and Automation:

- Provide expertise in configuring the CTMS (Veeva) to support effective risk-based monitoring.

- Ensure the CTMS is set up to automate risk-based monitoring tasks, reports, and alerts.

- Train the internal teams on the CTMS configuration and utilization for risk-based monitoring.

3. Risk Management Framework Development:

- Assist in developing a comprehensive risk management framework for clinical trials.

- Integrate risk-based monitoring principles and practices into the overall risk management strategy.

- Collaborate with the clinical project management and data management teams to implement the risk management framework.

4. Knowledge Transfer and Capacity Building:

- Provide hands-on training and mentorship to the internal teams on sponsor-side risk-based monitoring best practices.

- Facilitate knowledge transfer sessions to build the team's expertise in risk-based monitoring.

- Develop training materials and documentation to support the team's ongoing development.

Qualifications:

1. Extensive experience in implementing and managing risk-based monitoring at a sponsor organization.

2. Deep understanding of CTMS configuration and automation for risk-based monitoring.

3. Proven track record in developing and implementing risk management frameworks for clinical trials.

4. Strong technical expertise in risk-based monitoring methodologies, tools, and reporting.

5. Excellent communication and training skills to effectively transfer knowledge to the internal teams.

6. Ability to work collaboratively with cross-functional teams and adapt to the organization's culture and processes.

7. Familiarity with the regulatory landscape and industry guidelines related to risk-based monitoring.