Clinical Research Manager, Immunology, Remote
$142,400–$224,100 year
RemoteUnited States
Job Summary
Manage end-to-end project performance for assigned immunology protocols in compliance with ICH-GCP and local regulations. Serve as the primary point of contact linking Country Operations to the clinical trial team, driving execution from feasibility and site selection through recruitment and closeout. Lead local study teams by training Clinical Research Associates and Coordinators, conducting quality control visits, and executing risk management plans. Collaborate with investigators, vendors, and internal stakeholders to resolve challenges such as recruitment bottlenecks or performance issues, while maintaining oversight of Clinical Trial Management Systems and Electronic Trial Master Files. Travel up to 30% of the time to support on-site activities and build relationships with external partners.
Required Qualifications
- 5+ years of experience in clinical research
- Bachelor's degree in science (or comparable)
- Knowledge in Project Management
- site management
- Strong organizational skills
- Ability to make decisions independently
- Strong understanding of local regulatory environment
- Strong scientific and clinical research knowledge
- Strong understanding of clinical trial planning, management and metrics
- Ability to focus on multiple deliverables and protocols simultaneously
- Experience functioning as a key link between Country Operations and Clinical Trial Teams
- Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery
- Proficiency in written and spoken English and local language
- Competent and effective in written and verbal communication
- Strategic thinking
- Ability to work efficiently in a remote and virtual environment
- Understand cultural inclusion
- Proven strong project management skills and/or project management certification or relevant training program/close mentoring
- Strong leadership skills that enable and drive alignment with the goals, purpose and mission of our Company's Research Labs (CRL), Global Clinical Development (GCD) and Global Clinical Trial Operations (GCTO)
- Ability to identify problems, conflicts and opportunities early and lead, analyze and prepare mitigation plans and drive conflict resolution
- Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption
- Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders
- Up to 30% of working time travel
- Valid driving license
Desired Qualifications
- Clinical Research Associate (CRA) experience
- Immunology experience
- Trial management experience
- Advanced degree (e.g., Master degree, MD, PhD)
- Clinical Study Management
- Deliverables Management
- Leadership
- Peer Mentoring
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