Job Description Summary
The Study & Site Operations (SSO) Study Start-Up (SSU) Team Lead is accountable for the governance and oversight of a study start-up team in a standalone country. The SSO Study Start-Up Team Lead is supporting the country SSU strategy and prioritization in close collaboration with SSU Head and Country LT to deliver operational excellence of the GDD portfolio in compliance with Novartis processes, ICH/GCP and regulatory 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.
LI-#Remote
Job Description
Key Responsibilities:
Study Start-Up Strategy
• Supports 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
• Seeks and evaluates external knowledge and best practices to enhance overall operational excellence of country trial operations
• Supports country SSU strategy in close collaboration with SSU/OPC Head and Portfolio Head/Portfolio Team Lead(s)
• Responsible for timely start-up activities from country allocation until site Green Light (ready-to-initiate-sites)
• Ensures close collaboration with local IRBs/IECs and Health Authorities, as applicable
Allocation, initiation and conduct of trials
• Collaborates with Head Portfolio, SSO Portfolio Team Leads and global study team (Clinical Operations Program Head, Trial Lead) 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
• Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
• Implements innovative and efficient processes which are in line with Novartis strategy
People and resource management
• Hiring, training, development, and retention of Study Start-Up associates
• Resource management and reporting of Study Start-Up associates
• Ensures associates have the required level of skills to successfully set-up and execute studies with high quality and according to business objectives
• Manages and oversees productivity targets per defined objectives, and serves as an escalation point for Study Start-Up functions
Role Requirements:
• A degree in scientific or health discipline required
• Minimum 5 years' experience in clinical operations and planning
• Proven leadership capabilities and experience (with or without direct line management responsibilities).
• 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 strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/national Health Authorities regulations
• Strong capability in working in a global/country matrix environment
• Proven successful leadership of teams (with or without direct reports), preferably with experience in working with international teams
• Strong interpersonal, negotiation and conflict resolution skills
• Communicates effectively in a local/global matrixed environment
The salary for this position is expected to range between $138,600 and $257,400 per year.
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
To learn more about the culture, rewards and benefits we offer our people click here.
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
$138,600.00 - $257,400.00
Skills Desired
Budget Management, Clinical Trials, Negotiation Skills, People Management, Process Improvement, Project Planning, Vendor Management, Waterfall Model
