Senior Study Leader

Job Description Summary

Oversees all operational aspects of clinical trials end-to-end including the planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations. Complete oversight of budget and resource allocation within assigned trial. Drives operational excellence through process improvement and knowledge sharing across trials within program / franchise. Enables an empowered organization that can navigate in a matrix environment and adjust quickly to business needs. Point of escalation for resolution of trial management operational issues within assigned trial.

Job Description

Key Responsibilities :

• Leads the clinical trial team with per needed-basis oversight from the Study Director-community Lead (SD-CL) and delivery of multiple medium to complex global studies and promotes learning, sharing, consistent performance, and operational excellence through an agile attitude, agile principles, and a team of teams' model
• Acts as the CTT product owner with duties and responsibilities per established ways of working
• Guides planning and decision making at the study level and delivers assigned clinical study / studies per the Operational Execution Plan (OEP) and clinical study protocol
• Fosters an agile culture within assigned studies to achieve sprint goals and cycles, enhancing collaboration and minimizing dependencies to achieve long-term business impact
• In collaboration with regulatory writing and clinical development, promotes operational excellence in the development of global clinical study protocol(s), by translating the approved study concept sheet(s) into efficient, high quality, executable clinical protocols, and study-related documents
• Create effective CTT dynamics and achieve on performance, prioritization, and communication in close collaboration with CTT sub-team leaders
• Proactive risk management and inspection readiness
• Responsible for developing clinical study timelines with per needed-basis oversight from the Study Director-community Lead (SD-CL) and being responsible for assigned study budgets
• Ensures systems are maintained with up-to-date study status, risks , and issues
• Fosters a close working relationship with SSO Clinical Project Managers (CPMS) to strengthen the relationship between the global and local teams

Key performance indicators :

Essential Requirements :

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 / 2025, 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 Novartis : Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https : / / www.novartis.com / about / strategy / people-and-culture

Benefits and Rewards : Read our handbook to learn about all the ways we'll help you thrive personally and professionally : https : / / www.novartis.com / careers / benefits-rewards

Commitment to Diversity & Inclusion : 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.

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

Auditing, Clinical Monitoring, Clinical Research, Clinical Trials, Data Management, Global Project Management, Health Sciences, Lifesciences

Salary : $145,600 - $270,400