GCP Compliance Manager (Americas Hub)

Job Description

100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine - imagine the impact you could have in! #GCO

The Good Clinical Practice (GCP) Compliance Manager (Americas Hub) is accountable for the compliance oversight and control of regulated GCO activities focusing on Americas Hub & Country level delivery including country trial level conduct as per country assignment. This role contributes to all compliance activities supporting the three pillars of GCP Compliance, issue management, audits & inspections as per country assignment and GCO self-strategy delivery.

Your key responsibilities, but not limited to:
• Single point of contact for Americas Hub & Country team members for GCP Compliance
• Management and day-to-day support provided in program/trial level quality issues, deviations and quality events management
• Coordination and support to program / trial delivery teams for audits and inspections based on trials’ selection and audit / inspection scope
• Delivery of the GCO self-assessment strategy related checks and controls
• Support cross-functions risk assessments if program/trial/country level in scope and contribute to the monitoring of relevant indicators/metrics/thresholds
• Contribute to the execution of the GCO GCP Compliance strategy under the leadership of the GCP Compliance Head (Americas hub)
• Drive the compliance oversight and control of regulated GCO activities focusing on Americas Hub & Country level delivery including country trial level conduct as per country assignment, working closely with the Hub & Country teams members, the relevant functions across GCO, involving and collaborating as required with GDD and the wider organization, such as Quality Assurance
• Be the single point of contact for Americas Hub & Country team members as per country assignment for GCP Compliance

The ideal location for this role is East Hanover (or any other primary Novartis work site including Indianapolis, IN or Forth Worth, TX), but employees with an existing Distant Working Arrangement (DWA) or remote designation who have been impacted through restructuring will be considered for a DWA. Please note that this role would not provide relocation as a result. All home office expenses and any travel/lodging to a primary work site for periodic live meetings will be at the employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. If you are an Internal Novartis Associate who has already applied to (reference original BR #), your application will be considered in this same pool and you are not required to reapply. Please log in to your BrassRing profile for your status on the position.

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

What you’ll bring to the role:
• 8+ years industry experience specifically in clinical operations and clinical site management with a strong understanding of clinical research international standards and regulatory requirements from Health Authorities. Audits and inspections experience highly desirable
• Organizational and analytical skills associated with an aptitude in quality management and continuous improvement
• Critical thinking ability and risk management and risk-based knowledge and mindset
• Ability in partnering with a proactive and solution-oriented mindset
• Strong skills to facilitate/optimize contribution of team members as individuals and members of a cohesive team
• Ability to work effectively in a matrix cross-functional environment
• Strong capacity for working independently with minimal guidance
• Ability to make & communicate difficult decisions, associated with strong written and verbal communication skills.

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could achieve here at Novartis!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

US Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability 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.

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

The pay range for this position at commencement of employment is expected to be between $158,400 - $237,600/ year; however, while salary ranges are effective from 1/1/23 through 12/31/23, 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.