Senior Study Leader
Senior Study Leader
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$ 145600 - 270400
1 Vacancy
Job Description
Job Description Summary
Oversees all operational aspects of clinical trials endtoend 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 neededbasis oversight from the Study Directorcommunity Lead (SDCL) 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 longterm 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 studyrelated documents
- Create effective CTT dynamics and achieve on performance prioritization and communication in close collaboration with CTT subteam leaders
- Proactive risk management and inspection readiness
- Responsible for developing clinical study timelines with per neededbasis oversight from the Study Directorcommunity Lead (SDCL) and being responsible for assigned study budgets
- Ensures systems are maintained with uptodate 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:
- Excellence in execution and implementation of clinical operations strategy Timely efficient and quality execution of assigned trial and trial related activities within budget and in compliance with quality standards.
- Proactive operational planning with effective contingency and risk mitigation plans.
- Cost effective management of budget and resources with limited unforeseen cost overruns.
Essential Requirements:
- Bachelors degree in Life Sciences/healthcare (or clinically relevant degree) is required. Advanced degree strongly preferred.
- 4 yrs 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
- 3 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.
The pay range for this position at commencement of employment is expected to be between $145600 and $270400 /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 signon 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 atwill 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 and Rewards: Read our handbook to learn about all the ways well help you thrive personally and professionally: 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 email to or call 1(877)and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$145600.00 $270400.00Skills Desired
Auditing Clinical Monitoring Clinical Research Clinical Trials Data Management Global Project Management Health Sciences LifesciencesRequired Experience:
Senior IC
Employment Type
Full-Time
