Study Manager, Clinical Operations

About the role

This position contributes to the operational planning and execution of one or more clinical trials. In this role, you will have the opportunity to develop your leadership and technical skills as part of a global, cross-functional team. You will apply project management, communication, and collaboration skills in support of our clinical trials.

Responsibilities

• May have specific operations responsibilities for a single study or across multiple studies (e.g. operational deliverables, clinical & ancillary supplies planning, lab specimen tracking, status update reports, study close-out activities).
• May be responsible for tracking study timelines using project management tools.
• Shares technical expertise with team members.
• Makes interactions with internal and external stakeholders (e.g. study team, vendors, committees) in support of clinical trial objectives.

Core Skills

• Working knowledge of clinical research regulatory requirements (e.g. GCP and ICH)
• Good understanding of the principles of project planning & project management
• Building analytical skills to drive operational milestones
• Interact with key stakeholders across department, division and company
• Proactive approach driving toward study goals
• 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.)

Requirements

• Bachelor’s Degree +2 years of pharmaceutical, clinical drug development, project management, and/or medical field experience
• Master’s Degree +1 year of pharmaceutical, clinical drug development, project management, and/or medical field experience
• Education in life sciences, preferred

Preferred Skills

• Clinical Research
• Clinical Study Design
• Clinical Trial Compliance
• Clinical Trials
• Clinical Trials Operations
• Data Management
• Ethical Standards
• Project Management
• Regulatory Compliance
• Stakeholder Alignment
• Structured Content Management