Study Director Study Site Operations
Study Director Study Site Operations
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$ 185500 - 344500
1 Vacancy
Job Description
Job Description Summary
Accountable independently for the and delivery of the GCO supported clinical studies of medium to highly complexity and of high priority for Novartis per the Operational Plan (OEP) and clinical study protocol.The Study Director coleads together with the Clinical Science Lead (CSL)the crossfunctional clinical trial team (CTT) guides planning and management of the assigned clinical study/studies endtoend 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. Oversee budget and people allocation within assigned study/studies.
Job Description
Key Responsibilities:
- Coleads with the CSL the clinical trial teamin collaboration with the Clinical Operations Program Head (COPH) delivery of multiple complex global studies and promotes learning sharing consistent performance and operational excellence through an agile mindset agile principles and a team of teams model
- Guides planning and decision making at the study level and delivers assigned clinical study/studies per the Operational Plan (OEP) and clinical study protocol
- 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. Ensures systems are maintained with uptodate study status risks and issues
- Responsible for developing clinical study timelinesin collaboration with the Clinical Operations Program Head (COPH) and overseeing assigned study budgets
- Oversees study recruitment and responsible for activating mitigation strategies in collaboration with the SSO Clinical Program Managers (CPMs)
- Ensures proper handling of all study close out activities including but not limited to site close out final drug accountability and audit readiness of Trial Master File documentation
- Promotes operational excellenceand contributes to the development of Clinical Study Reports; reporting of clinical study results and internal/external publications when appropriate
- Achieves excellence in study operations and management through process improvement in collaboration with the Study Leadership Community Lead and GCO Process Training and Compliance (PTC)
Essential Requirements:
- Education: Bachelors degree in life sciences/healthcare (or clinically relevant degree) is required. Advanced degree is strongly preferred.
- 7 years of recent involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV studies of medium to highly complexity
- 35 years of recent contribution to and accomplishment in all aspects of conducting clinical studies of medium to highly complexity and of high priority for Novartis (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 (GCP/ICH) health authorities (FDA/EMA) local/National Health Authorities regulations
- Management of virtual teams. Proven ability and strong experience leading teams and building capabilities
- Experience in developing effective working relationships with internal and external stakeholders
- Excellent communicator and presenter (oral and written); ability to communicate at all levels
- Excellent negotiation and conflict resolution skills and enterprise mindset
- Strong project management skills and demonstrated ability to meet timeline
- Proven track record in study operations process improvement(s)
The pay range for this position at commencement of employment is expected to be between $185500 and $344500/year; however while salary ranges are effective from 1/1/25 through 12/31/25 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: 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 calland let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$185500.00 $344500.00Skills Desired
Agility Budget Management Clinical Monitoring Clinical Research Clinical Trials Lifesciences Resource Management (Organizational)Required Experience:
Director
Employment Type
Full-Time
Key Skills
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