Study Leader

4 weeks ago

East Hanover, United States Novartis Full time

**About the Role**:
Responsible with per needed-basis oversight from the Study Director community Lead (SD-CL) for the execution and delivery of the GCO supported clinical studies of standard to medium complexity and priority per the Operational Execution Plan (OEP) and clinical study protocol.
The Senior Study Leader is the leader of the cross-functional clinical trial team (CTT), guides planning and management of the assigned clinical study/studies end-to-end to achieve Global Program Team (GPT), Global Clinical Team (GCT) and GCO objectives.
Accountable for proactive, iterative operational planning with effective contingencies and embedded risk management mindset in CTT. Be responsible for budget and people allocation within assigned study/studies.
Contribute in promoting operational excellence through process improvement and knowledge sharing across studies. Cultivate an empowered, psychologically safe organization that can navigate a matrix environment, learns, and adjusts quickly to changing conditions and business needs.
Your Key Responsibilities:
1. 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
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, enhancing 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 study 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 per needed-basis oversight from the Study Director-community Lead (SD-CL) and being responsible for 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 Project Managers (CPMS) to strengthen the relationship between the global and local teams

**Diversity & Inclusion / EEO**:

- We 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._

**Role Requirements**:

- Bachelors degree in Life Sciences/healthcare (or clinically relevant degree) is required. Advanced degree preferred.
- 2 year 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 to high complexity and priority
- 1 years of recent contribution to and accomplishment in all aspects of conducting clinical studies of standard to high complexity and priority (e.g., planning, driving, reporting and publishing) in a global/matrix environment in pharmaceutical industry or a contract research organization, including expert knowledge of international standards (GCP/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 strong experience leading teams and building capabilities
- Experience in developing effective working relationships with internal and external partners.

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

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $130,400/$195,600year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjus

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