Overview
This is a remote position for a Clinical Research Associate Manager (CRAM). The role oversees CRA performance, development and coaching to drive mindset and behavior, manages CRA performance targets per defined KPIs (delivery, productivity, quality), and liaison with CPMs to ensure timely data collection and data cleaning. This position can be based remotely anywhere in the U.S. (some legal entity restrictions may apply); it requires up to 80% travel and no relocation provided. Working hours and travel expectations are defined by the hiring manager.
Base pay
$145,600.00/yr - $270,400.00/yr
Key Responsibilities
• Accountable for monitoring quality, timely data entry and issue resolution.
• Identify and resolve CRA monitoring competency gaps through targeted training in collaboration with the training group and by performing co-monitoring visits with training purposes.
• Actively manage CRA team performance, including implementing development and performance improvement plans.
• Execute annual CRA oversight visit plan to assess monitoring competency, identify issues, and develop resolution strategies.
• Ensure adherence to clinical data standards, GCP/ICH, regulatory requirements, ethical guidelines, and SOPs.
• Support clinical development audits, site audits and inspections; ensure CAPA follow-up and implementation for CRA and site issues.
• Ongoing assessment and allocation of monitoring resources to balance CRA workload and quality monitoring within countries.
• Monitor, track and approve CRA travel and expenses to ensure compliance with T&E policy and budget.
Essential Requirements
• Bachelor’s degree (4-year) plus relevant healthcare experience.
• Minimum 7 years’ experience in clinical research—planning/executing and/or monitoring clinical trials.
• Field monitoring experience.
• Leadership experience with project management and team leadership capabilities.
• Comprehensive understanding of clinical drug development, especially monitoring and trial execution.
• Strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local regulations, risk-based monitoring, and Novartis standards.
Desirable Requirements
• Advanced degree.
• Experience managing and leading a team of CRAs.
Driving
Driving is an essential function of this role. A fully valid and unrestricted driver’s license is required to qualify for the position. Reasonable accommodations are provided if they do not eliminate the essential function.
COVID-19 Policy
In customer-facing roles, vaccination or adherence to credentialing guidelines may be required by customers. We consider accommodation requests as required by law. See policy for details.
EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility & Accommodations
The Novartis Group of Companies are committed to providing reasonable accommodations to individuals with disabilities during the application process or to perform essential job functions. Please contact the provided channels with your request and include the job requisition number.
Why Novartis: We aim to improve lives through science and collaboration. Learn more at the company site and join our network for updates on opportunities.
#J-18808-Ljbffr