Summary
The Study Leader Is responsible for the appropriate oversight from the Study Director-community Lead (SD-CL), for the execution and delivery of GCO supported clinical Studies of standard complexity and priority, per the Operational Execution Plan (OEP) and clinical study protocol.
#LI - Hybrid
Your Key Responsibilities:
1. Leads the clinical trial team with the appropriate oversight from the Study Director-community Lead (SD-CL) and close support from the Clinical Operations Program Head (COPH), delivery of multiple global studies of standard complexity and priority and promotes learning, sharing, consistent performance, and operational excellence through an agile mindset, agile principles, and team of teams’ model
2. Acts as the CTT product owner with duties and responsibilities per established ways of working
3. 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
4. Fosters an agile culture within assigned studies to achieve sprint goals and cycles, maximizing collaboration and minimizing dependencies to achieve long-term business impact
5. In collaboration with regulatory writing and clinical development, promotes operational excellence in the development of global clinical trial protocol(s), by translating the approved study concept sheet(s) into efficient, high quality, executable clinical protocols, and study related documents
6. Create effective CTT dynamics and achieve on performance, prioritization, and communication in close collaboration with CTT sub-team leaders
7. Proactive risk management and inspection readiness
8. Responsible for developing Clinical study timelines with appropriate oversight from the SD-LC and close support form the Clinical Operations Program Head, an overseeing assigned study budgets
9. Ensures systems are maintained with up -to-date study status, risks, and issues
10. Fosters a close working relationship with SSO Clinical Program Managers to strengthen the relationship between the global and local teams
About the Role
Role Requirements:
- Bachelor’s degree in life sciences/healthcare(or clinically relevant degree) is strongly preferred. Advanced degree is preferred.
- >2 years of recent involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV of standard complexity and priority
- >1 year of recent contribution to and accomplishment in all aspects of conducting clinical studies of standard complexity and priority (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry or a contract research organization, including expert knowledge of international standards (GFP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards
- Experience in managing people globally in a complex matrix environment preferred
- Management of virtual Teams. Proven ability and experience leading.
- Experience in developing effective working relationships with internal and external stakeholders
- Good communicator and presenter (Oral and Written)
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $130,400-$195,600 annually; however, while salary ranges are effective from 1/1/24 through 12/31/24, 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.
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EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. 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. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.
Accessibility & 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 [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.
