摘要
The Field Monitoring Head will provide expertise/strategic guidance to associates within the organization to execute the field monitoring strategy and will work closely and collaboratively with other senior and functional leaders to ensure fully harmonized and integrated strategies and operations to drive successful portfolio planning and execution. Responsible to coordinate and lead the Country field team, including Clinical Research Associates (CRA), CRA Managers, Monitoring Services Oversight Managers and Field Monitor Director Area Heads. in the areas of functional management. Ensures technical and capability training plans are in place with the Global training organizations and sets culture for continued growth and development of the field monitoring organization countrywide. Accountable for overall country CRA resource management strategy as well as financial oversight, vendor management, and acts as an escalation point for FSP issues in order to optimize FSP collaboration and partnership in the country. Oversees CRA quality and performance indicators and ensures ICH/GCP compliance.
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 20% travel
#LI-Remote
About the Role
Key Responsibilities:
- Drives program and trial field monitoring strategy to achieve Global, Hub and Local business objectives.
- Creates and implements. innovative practices and site engagement tactics to advance field planning, execution, patient engagement and quality in line with Study & Site Operations (SSO) strategies and objectives.
- Ensures trial execution is according to enrollment commitment, timelines, and budget; tracks performance through key performance indicators; drives Hub re-allocation or corrective action when needed in partnership with the SSO Hub Head Portfolio.
- Builds competitive advantages for global development trials within the Country/Cluster considering medical standard of care, competitive environment, and local business drivers.
- Accountable for Field Monitoring quality and issue resolution through timely review, approval, resolution and/or escalation of KPIs.
- In partnership with the SSO Strategy & Operations Country/Regional Head, responsible for development and delivery of a country resourcing strategy aligned with the Hub Resourcing strategy.
- Responsible for the hiring, training, development, and retention of a team of Field Monitoring staff to deliver quality monitoring to the Innovative Medicines Phase I-IV Global Drug Development (GDD) trials
- Performs ongoing assessment and allocation of monitoring resources to ensure balanced staff workload.
- Establishes a process for managing performance (recognition/corrective action) to ensure delivery to the established Key Performance Indicators (KPI)/ Key Quality Indicators (KQI)
- Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times
- Accountable for adequate CRA monitoring competency based on technical and capability training plans for Field Monitoring Director Area Heads, CRA Managers, Monitoring Services Oversight Managers, and CRAs. Ensures management teams have plans for oversight of CRA work responsibilities as well as professional development.
- Responsible for managing and addressing staff performance targets per defined quality performance indicators. Budget and productivity
Role Requirements:
- A degree in scientific or health discipline required and advanced degree preferable
- Minimum 10 years’ experience in clinical research - planning/executing and/or monitoring clinical trials
- Experience and evidence of team leadership capabilities
- Understanding of all aspects of clinical drug development with particular emphasis on trial execution
- Stakeholder management capabilities with demonstrated capability to problem solve and mediate complex issues.
- Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations and Novartis standards
- Good understanding of the Risk Based Monitoring process and requirements
- Demonstrated negotiation and conflict resolution skills
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.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between:$204,400 and $379,600/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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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 & Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
