Associate Director, Monitoring Oversight Management

Bachelor's degree in a scientific or healthcare-related field. Minimum of 8-10 years of experience as a CRA or related role within the pharmaceutical or biotechnology industry. Minimum 5 years of experience leading a team of CRAs. Recent experience working on respiratory, dermatology and / or gastrointestinal clinical trials preferred. Experience working in Phase I – III clinical trials. Recent experience working on trials utilizing risk-based monitoring models. Strong knowledge of International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP) and FDA regulations. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Smartsheet. Experience with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems. Strong understanding of clinical trial processes and study conduct. Excellent organizational and time management skills. Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment and can also work independently without significant oversight. Experience working in a fast-paced and dynamic environment. Certification as a Clinical Research Associate (CCRA) or equivalent preferred.

Lead Oversight CRAs globally to ensure study deliverables are met with efficiency and quality. Responsible for hiring in-house Oversight CRAs. Assist with creation, review and revision of departmental SOPs and policies. Lead regular meetings with Oversight CRA team and individual CRAs. 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. Contribute to development and implementation of risk-based monitoring strategies. Assist monitoring head with resourcing/capacity management projections. Contribute to overall operational readiness to support clinical operations monitoring oversight activities. Facilitate resolution of region specific and site management related challenges. Communication and issue resolution with clinical vendors. Create and implement monitoring processes, tools, and documents. Periodic review of monitoring visit reports and metrics. Responsible for ensuring Oversight CRAs maintain their sites as inspection ready. Compile and provide clinical monitoring metrics per KPIs. Support and liaise with clinical site personnel. Review and approve time sheets and expense reports. Conduct periodic quality visits for Senior Oversight CRAs. Ensure all site oversight visits are completed within the expected timelines globally. Oversee all timelines and KPIs for the oversight monitoring team globally. Ensure oversight CRAs review and ensure data integrity, accuracy, and completeness at clinical study sites.