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Senior Study Manager, Immunology
Job in
California, Moniteau County, Missouri, 65018, USA
Listed on 2026-09-12
Listing for:
Jobtailor
Full Time
position Listed on 2026-09-12
Job specializations:
-
Science
Clinical Research
Job Description & How to Apply Below
- Lead operational planning, feasibility, and execution of one or more clinical trials or significant aspects of trials in the Tulisokibart immunology program
- Serve as clinical trial team lead when needed
- Lead study planning, development, and execution elements, including data management deliverables, trial plans and timelines, country/site selection, site materials, system updates, investigator meeting planning, communication plans, status reports, and study closeout
- Lead timeline management, risk identification and mitigation, and issue resolution
- Facilitate collaboration with internal and external stakeholders, including study teams, country teams, vendors, and committees
- Manage study-specific partners and vendors
- Represent the company through external partnerships, collaborations, and strategic engagements
- Lead meetings and influence peers in a matrix environment
- Drive operational milestones and study goals
- Bachelor's Degree and 5+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR Master's Degree and 3+ years of such experience OR PhD/PharmD Degree
- Degree in life sciences preferred
- Experience conducting global clinical trials, including trial initiation through database lock
- Highly preferred: experience conducting clinical trials for Gastroenterology, Dermatology, or Rheumatology, especially autoimmune or immune-mediated disorders
- Experience managing and driving operational activities on protocols for immunology-related clinical trials
- Solid knowledge of clinical research regulatory requirements, including GCP and ICH
- Ability to manage multiple competing priorities
- Understanding of project planning and project management principles
- Analytical, problem-solving, prioritization, conflict-resolution, and critical-thinking skills
- Strong communication, writing, and presentation skills
- Intermediate knowledge of Microsoft Office or similar, including Excel, PowerPoint, Word, and Outlook
- No visa sponsorship
- 10% travel
- Valid driving license not required
Demonstrates expertise in leading clinical trial operations, including planning, execution, and compliance with regulatory requirements. Proficient in managing cross-functional teams and driving project milestones in the immunology domain.
Highest-signal resume keywords- Clinical Trial Management
- Project Management
- Regulatory Compliance (GCP, ICH)
- Immunology Clinical Trials
- Stakeholder Collaboration
- Clinical Drug Development
- Data Management
- Trial Planning
- Risk Identification and Mitigation
- Operational Activities Management
- Analytical Skills
- Problem-Solving Skills
- Project Planning Principles
- Strong Communication Skills
- Conflict Resolution
- Critical Thinking
- Prioritization Skills
- Clinical Trials
- Gastroenterology
- Dermatology
- Rheumatology
- Autoimmune Disorders
- Life Sciences
- Microsoft Office
- Excel
- Power Point
- Word
- Outlook
Position Requirements
10+ Years
work experience
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