Associate Director, Monitoring Services Oversight Management

Job Description Summary

About the role:
#LI-Remote
Primary contact for Full-Service Provider (FSP) and other monitoring services (vendors) to assure adequate quality of the services & performance in Novartis sponsored clinical trials. Oversees vendor monitoring performance targets per defined quality performance indicators, including site recruitment commitments, timely data entry and issue resolution Key Performance Indicators (KPIs). Aligns with FSP and other vendor’s managers on Clinical Research Associate and other vendor resource related allocation to trials and studies.

Job Description

Key Responsibilities:

• Ensures timely communication with vendors’ line managers to ensure sponsor requirements are up to date – sets up governance model
• Develop resource needs/expectations strategy and align with vendor line management (CRAs and other vendor resources)
• Collaborates with Clinical Research Associate (CRA) Manager and other internal stakeholders for country resource strategy to be best single point of contact/ primary interface FSP/other vendors
• 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
• Escalates non-compliance, performance issues, competency gaps and/or needs to vendors
• Oversees country trial site activation, enrolment, data flow and timeline commitments are delivered per established trial objectives
• Oversees monitoring quality, timely data entry and issue resolution including oversight of CRA oversight visit performance
• Oversee execution of annual CRA oversight visit plan to assess vendor issue management and oversight in close collaboration with FSP line management

Essential Requirements:

• 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 30-40% travel.
• A degree in scientific or health discipline required and advanced degree preferable (or, for United States: 4-year degree plus relevant, related healthcare experience).
• Minimum 7 years of experience in clinical research planning/executing and/or monitoring clinical trials.
• Experience and evidence of team leadership capabilities.
• Understanding all aspects of clinical drug development with particular emphasis on monitoring and trial execution.
• Fluent in both written and spoken English.
• Strong communication skills and ability to influence internal and external stakeholders in order to maximize quality and efficiency of external service providers.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between: $145,600 and $270,400/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.

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 and 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 us.reasonableaccommodations@novartis.com 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.

Salary Range

$145,600.00 - $270,400.00

Skills Desired

Budget Management, Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trials, Collaboration, Data Analysis, Decision Making Skills, Health Sciences, Lifesciences, People Management, Regulatory Compliance