Clinical Trial Manager

About the role

The Clinical Trial Manager (CTM) works closely with internal team members, vendors, and clinical study sites to ensure clinical trials are conducted in a timely and compliant manner with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets. This position is responsible for ensuring achievement of Omeros’ project goals and objectives and may have line management responsibilities. The CTM is able and willing to perform all duties or functions of subordinates.

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 (e.g., study management, monitoring, site management, project master files)
• Works with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensures that performance expectations are met
• Prepares and/or reviews/approves study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)
• Manages clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) 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 (informed consent template and study tools/worksheets), investigator contracts, and site payments
• Participates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
• Performs some or all of the Duties and Responsibilities outlined for Senior Clinical Research Associate, as needed

Requirements

• 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
• Familiar with advanced concepts of clinical research and able to work effectively in a team/matrix environment
• Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines
• Able to deal with time demands, incomplete information or unexpected events
• Able to provide clinical operations expertise to clinical development in a specified product areas and projects
• Able to travel approximately 10% overnight (50% or greater during peak times)

Behavioral Competencies Required

• Must possess excellent interpersonal skills
• Must have the ability to build and maintain positive relationships with management, peers, and subordinates
• Excellent written and verbal skills
• Must be able to develop and present varied and unique ideas
• Develops and provides challenging yet appropriate assignments and communicates progress toward objectives and goals
• Must display strong analytical and problem-solving skills. Attention to detail required

Supervisory Responsibilities

Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, directing work, and appraising performance. This position will also supervise work in a matrix organization.

Physical Demands Required

• May encounter prolonged period of sitting
• The employee may frequently be performing repetitive movements such as typing on a keypad or using a mouse
• The employee may climb, bend, reach, push, pull, balance, stoop, kneel, or crouch
• The employee must on occasion lift and/or move up to 25 pounds

Compensation and Benefits

Omeros offers a competitive total compensation package. The wage scale for this position is $125,000–$150,000; salaries are determined based on knowledge, skills, education, and experience relevant to the role.

• Medical, dental, vision, and life insurance
• 401(k) plan with company match
• Three weeks of vacation and 80 hours of sick time annually
• Twelve paid holidays throughout the calendar year
• Eligibility for incentive and stock options