Study & Site Operation (SSO) Study Start-Up Country Head, US - Remote
- East Hanover, New Jersey, United States
- Closing date
- Mar 28, 2023
100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations (GCO), 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 as the SSO Study Start-Up Country Head, US ! #GCO
In this position you'll be accountable for the governance and oversight of the study start-up team in the US, and the US SSU strategy and prioritization in close collaboration with SSO Country/Cluster Head Portfolio and SSO Country Head to deliver operational excellence of the GDD portfolio in compliance with Novartis processes, ICH/GCP and regulatory requirements.
Responsibilities include but are not limited to:
Study Start-Up Strategy
• Collaborate with Study & Site Operations Country Leadership Team to identify innovative practices to optimize country operations and operational excellence, especially in terms of study start-up activities to increase performance, productivity, and business impact
• Seek and evaluate external knowledge and best practices to enhance overall operational excellence of country trial operations. Define and continuously optimize country SSU strategy in close collaboration with SSO Country Head and SSO Country Head(s) Portfolio
• Accountable for timely start-up activities from country allocation until Green Light (ready-to-initiate-sites). Ensure close collaboration with local IRBs/IECs and Health Authorities, as applicable
Allocation, initiation and conduct of trials
• Collaborate with SSO Portfolio Head(s) & Team Leads, SSO Contract Payment Head and global study team to ensure SSU timelines and deliverables are met according to country commitments. Accountable for timelines, accuracy, and quality of TMF documents, including study start-up and ongoing TMF maintenance to ensure TMF inspection readiness
• Ensure adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements. Implement innovative and efficient processes which are in line with Novartis strategy
• Promote a compliance culture advocating the adherence to the highest standards and ethical integrity, always ensuring human subject protection and reliability of trial results
People and resource management
• Hiring, training, development, retention, resource management and reporting of SSU team. Ensure associates have the required level of skills to successfully set-up and implement studies with high quality and according to business objectives
• Manage and supervise productivity targets per defined objectives, and serve as an escalation point for Study Start-Up functions
Accessibility and accommodation:
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 in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877) 395-2339 and let us know that nature of your request and your contact information. Please include the job requisition number in your message.
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.
Required Experience & Qualifications:
• Educational minimum requirements: College or university degree with significant life science experience
• Minimum 8 years’ experience in clinical operations and planning and since this role will be directly leading a team of 10-12 people, a minimum 4 years’ experience in people management and team leadership, preferably with experience in working with international teams
• Excellent understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring
• Thorough understanding of the international aspects of drug development process, including solid understanding of international standards (GCP/ICH), health authorities (FDA/EMA), local/national Health Authorities regulations and Novartis standards
• Strong competence in working in a global/country matrix environment
• Strong interpersonal, negotiation and conflict resolution skills
• Communicates effectively in a local/global matrixed environment
The pay range for this position at commencement of employment is expected to be between $212,000-$318,000/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.
Why consider 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 do here at Novartis.
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