Associate Director, Monitoring Oversight Management
A
Apogee TherapeuticsBiotechnology
United StatesFull-TimeDirector
Salary180000 - 205000 USD per year
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Job Details
- Languages
- English
- Experience
- 8-10 years
- Required Skills
- LeadershipProject ManagementData AnalysisPeople ManagementCross-functional Team LeadershipOperations ManagementDocumentationMicrosoft Office SuiteMentoringComplianceTrainingRisk Management
Requirements
- 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.
Responsibilities
- 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.
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