Clinical Trials Operations Lead

Omeros Corporation; Seattle (WA); On-site; USD 125,000 - 150,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) with company match

Vacation and holidays

Job summary

Omeros seeks a Clinical Trial Manager to lead operational aspects of clinical trials, manage Clinical Operations personnel, and oversee study plans, timelines, budgets, and resources, ensuring compliance with SOPs and regulatory guidelines. The role requires a 4-year Life Science degree, 5+ years in trial management with 2+ years supervising, experience with CROs, and ability to travel about 10%.

Omeros offers competitive compensation, medical/dental/vision, 401(k) with match, vacation,

Qualifications

• A 4-year degree from a university with a related degree in a Life Science
• A minimum of 5 years of related clinical trial management experience with a minimum of 2 years of supervisory experience
• Experience in interactions with outside vendors, e.g., CROs and other vendors
• Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines

Responsibilities

• Manages the operational aspects of clinical trials
• Manages Clinical Operations personnel
• Manages the study project plan, including timeline, budget, and resources
• Participates in protocol, CRF and strategy development, Clinical Study Report preparation, NDA submission, as appropriate
• Prepares metrics and updates for management, as assigned
• Proactively identifies potential study issues/risks and recommends/implements solutions
• Participates in and facilitates CRO/vendor selection process for outsourced activities
• Manages CRO interactions, including sponsor oversight of operational functional activities
• Works with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines
• Prepares and/or reviews/approves study-related documents
• Manages clinical monitoring activities ensuring compliance with Good Clinical Practices and applicable regulations
• Participates in the development, review and implementation of departmental SOPs and processes
• Recommends and implements innovative process ideas to positively impact clinical trials management
• Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings
• Serves as a liaison and resource for investigational sites
• Reviews site study documents, investigator contracts, and site payments
• Participates in the selection, training and evaluation of study personnel
• Performs some or all of the Duties and Responsibilities outlined for Senior Clinical Research Associate, as needed

Skills

Project management

Vendor management

Clinical operations

Regulatory/compliance knowledge

Team leadership

Education

Bachelor's degree in Life Sciences

Job description

Omeros seeks a Clinical Trial Manager to lead operational aspects of clinical trials, manage Clinical Operations personnel, and oversee study plans, timelines, budgets, and resources, ensuring compliance with SOPs and regulatory guidelines. The role requires a 4-year Life Science degree, 5+ years in trial management with 2+ years supervising, experience with CROs, and ability to travel about 10%.

Omeros offers competitive compensation, medical/dental/vision, 401(k) with match, vacation,