02 Sep
Associate Director of Clinical Monitoring and Documentation
Vacancy expired!
- Ensure the standardization, consistency and quality of monitoring practices across clinical trials by ensuring compliance with policies, procedures and plans;
- Ensure the quality and integrity of data; conduct site quality trend analysis and data review including queries and protocol deviations, trouble shoot and problem solve issues, escalate to the clinical project manager (CPM) and/or head of clinical operations, as needed
- Responsible for the setup, oversight, and management of TMF vendors and/or systems
- Work in collaboration with study teams to establish study specific TMF specifications, structure and plans
- Implement TMF oversight plans inclusive of quality checks, risk assessment and mitigation analysis; triage and communicate quality issues and gaps, escalate as needed to study team and head of Clinical Operations
- Bachelor's Degree
- 7+ years of relevant monitoring and/or monitoring oversight experience with 3 years of direct monitoring experience, including lead CRA experience at a CRO or pharmaceutical /biotechnology company
- Experience with eTMF systems, set up and implementation, including specifications, policies, procedures and plans
- Advanced knowledge of clinical documentation and reporting
- Knowledge/understanding of DIA TMF Reference Model
- Ability to partner collaboratively with cross-functional team members and CRO staff
Vacancy expired!