Clinical Research Associate Manager (CRAM) - Remote Position

Job Description Summary

Oversight of CRA performance, development and coaching of CRA to drive mindset and behavior- responsible for managing and addressing CRA performance targets per defined KPIs: delivery, productivity, and quality performance indicators, including managing site recruitment commitments, timely data entry and issue resolution. People and resource management – ongoing assessment of allocation of CRAs to studies and sites. Budget oversight – monitors and approves CRA travel and expense to ensure compliance to T&E policy, and to ensure local targets for travel budget are met. Ensures CRA monitoring competency gaps are identified and resolved through targeted coaching and training curricula in collaboration with training group. Liaise on ongoing basis with CPMs to ensure enrollment, data collection and data cleaning are executed by CRAs in a timely manner.

This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 80% travel.
#LI-Remote

 

Job Description

Your Key Responsibilities:

• Accountable for monitoring quality, timely data entry and issue resolution
• Ensures CRA monitoring competency gaps are identified and resolved through targeted training curricula in collaboration with training group as well as by performing co-monitoring visits with training purposes 
• Actively manage CRA team performance including implementation of development and performance improvement plans
• Is responsible for execution of annual CRA oversight visit plan to assess ongoing CRA monitoring competency, identifying issues, and developing resolution strategies
• Ensures adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
• Supports Clinical Development Audits, site audits and inspection and ensures CAPA follow-up and implementation for CRA and site identified issues
• Performs ongoing assessment and allocation of monitoring resources within countries to ensure balanced CRA workload for quality monitoring
• Monitors, tracks and approves CRA travel and expense to ensure compliance to T&E policy and budget

Essential Requirements:

• 4-year degree plus relevant, related healthcare experience
• Minimum 7 years’ experience in clinical research -planning/executing and/or monitoring clinical trials
• Field Monitoring experience
• Leadership experience
• Experience in project management and evidence of team leadership capabilities
• Understanding of all aspects of clinical drug development with particular emphasis on monitoring and trial execution
• Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations, risk-based monitoring and Novartis standards

Desirable Requirements:

• Advanced Degree
• Experience managing and leading a team of CRA’s

Driving is an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver’s license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. 

COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com. 

The salary for this position is expected to range between $145,600 and $270,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experi