Study Manager, Clinical Operations

• Contributes to the operational planning and execution of one or more clinical trials
• Develop leadership and technical skills as part of a global, cross-functional team
• Apply project management, communication, and collaboration skills in support of clinical trials
• Responsible for operational deliverables such as clinical & ancillary supplies planning, lab specimen tracking, status update reports, study close-out activities
• Track study timelines using project management tools
• Interact with internal and external stakeholders (e.g. study team, vendors, committees) in support of clinical trial objectives

• Bachelor’s Degree +2 years of pharmaceutical, clinical drug development, project management, and/or medical field experience
  -OR
  - Master’s Degree +1 year of pharmaceutical, clinical drug development, project management, and/or medical field experience
• Degree in life sciences, preferred
• Working knowledge of clinical research regulatory requirements (e.g. GCP and ICH)
• Ability to manage multiple competing priorities with good planning, time management and prioritization skills
• Good understanding of the principles of project planning & project management
• Building analytical skills to drive operational milestones
• Problem solving, prioritization, conflict resolution, and critical thinking skills
• Solid communication, writing and presentation skills
• Intermediate knowledge in Microsoft office or similar (Excel, PowerPoint, Word, Outlook, etc.)

Demonstrates expertise in project management and operational planning for clinical trials, with a strong understanding of regulatory requirements and the ability to effectively communicate and collaborate with diverse stakeholders.

• Project Management
• Clinical Trial Operations
• Regulatory Compliance (GCP, ICH)
• Communication Skills
• Time Management

• Clinical Drug Development
• Operational Planning
• Lab Specimen Tracking
• Status Update Reporting
• Project Planning Principles
• Analytical Skills

• Problem Solving
• Prioritization
• Conflict Resolution
• Critical Thinking

• Pharmaceutical
• Clinical Research
• Life Sciences

• Microsoft Office
• Excel
• Power Point
• Word
• Outlook