Associate Director, Monitoring Oversight Management
About the role
Role Summary
We are seeking an Associate Director, Monitoring Oversight Management, to manage Apogee’s Oversight CRAs who will oversee the performance of CRO monitoring and site management related activities for Apogee sponsored clinical trials. This role will also support contract Oversight CRAs globally. In this role, you will serve as Apogee’s primary liaison with the in-house Oversight CRAs and Lead CRAs and contribute to building a culture of team, site and patient centricity. Helping Apogee become “Sponsor of Choice” with both our CRO partners and sites will be critical. This role will also contribute to monitoring related process development, continuous evaluation of monitoring related resourcing, and the development and implementation of risk-based monitoring strategies.
Key Responsibilities
- In-house responsibilities
- The Associate Director of Monitoring Oversight Management is responsible for the leadership of Oversight CRAs globally driving the team to ensure study deliverables are met with efficiency and quality and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices (GCP), Key Performance Indicators (KPs), and study-specific requirements
- Responsible for hiring in-house Oversight CRAs
- Assist with creation, review and revision of departmental SOPs and policies, as applicable
- Lead, conduct, and document regular meetings with Oversight CRA team and with individual CRAs to disseminate timely and relevant updates and best practices for consistency and efficiency
- Assist with creation and delivery of department initiatives, improvement plans and/or training
- Create SOPs and process to support the responsibilities of the monitoring excellence organization
- Responsible for the training and development of in-house Oversight CRAs and ensuring training compliance is maintained
- Contribute to development and implementation of risk-based monitoring strategies
- Assist monitoring head with resourcing/capacity management projections across clinical studies