Sr. Clinical Trial Manager

Sr. Clinical Trial Manager

Position Summary:

The Sr. Clinical Trial Manager (CTM) is a highly motivated team player responsible for the oversight and execution of the operational aspects of one or more clinical studies. The CTM works closely with various internal team members and vendors as well as clinical study sites to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets. The Sr. CTM is accountable for the day-to-day operational oversight including study start-up, conduct, and close out activities. This position is responsible for ensuring achievement of Omeros’ clinical trials.

Good things are happening at Omeros!

Come join our Omeros Clinical Operations Team!

Who is Omeros?

Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases) and cancers. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome, and COVID-19. OMS906, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial. For more information about Omeros and its programs, visit www.omeros.com.

Essential Duties & Responsibilities:

• Devises efficient, effective clinical trial execution strategies; guides planning and execution of clinical studies, including management of study budgets / timelines and external vendor(s) management
• Participates in the preparation/ review/ approval of study documents including but not limited to Informed Consent Forms and other patient facing material, protocol, CRF and guidelines, study plans and manuals, regulatory submissions, and strategy development
• Prepares key study metrics and updates for management and determines appropriate actions in conjunction with the study team
• Demonstrate initiative and problem-solving skills by offering solutions when obstacles are identified, and escalated to leadership when appropriate
• Participates in and facilitates CRO/vendor selection process for outsourced activities
• Manages CRO and vendor interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, trial 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
• Perform study related tasks including but not limited to cross function data review and ensuring sites manage data entry and query responses, IP release packet review, conduct investigator meetings, quality event reporting and CAPA implementation
• Prepares and/or reviews/approves and oversee compliance with study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)
• Oversees the clinical trial activities ensuring compliance with the protocol, SOPs, ICH-GCP, and applicable regulations
• Participates in the development, review and implementation of departmental SOPs and processes
• 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
• Provides mentorship and oversight for other Clinical Operations team members

Education, Experience, Knowledge & Skills Required:

• A 4-year degree from a university with a related degree in a Life Science
• 8+ years of related clinical trial management experience with a minimum of 1-3 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
• Recommends and implements innovative process ideas to positively impact clinical trials management
• Ability to provide clinical operations expertise to cross functional peers, able to work effectively with peers in a team/ matrix environment
• Must possess excellent interpersonal skills
• Excellent written and verbal communication skills
• Display strong analytical and problem solving skills; attention to detail is a must
• Experience in Phase 3 clinical trials and rare disease preferred

Behavioral Competencies Required:

• Must have the ability to build and maintain positive relationships with management, peers, and subordinates
• Must be able to develop and present varied and unique ideas and communicate progress towards study objectives and goals
• Ability to work with urgent requests, incomplete information or unexpected events

Supervisory Responsibilities:

• Provide leadership and direction to the study management team members from study start through to closure
• May manage Clinical Operations personnel
• Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws
• Responsibilities may include interviewing, hiring, and training employees; planning, assigning, directing work, and appraising performance

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

Other Requirements:

• Ability to travel approximately 10% overnight (50% or greater during peak times)

Compensation and Benefits

Omeros is proud to offer a competitive total compensation package designed to support the lives of our employees and their families. The wage scale for the Sr. Clinical Trial Manager role is $135,000 - $158,000. Salaries will be determined based on knowledge, skills, education, and experience relevant to the role. Employees are offered medical, dental, vision, life insurance, and a 401(k) plan with a company match. Employees accrue three weeks of vacation and 80 hours of sick time on an annual basis and receive twelve paid holidays throughout the calendar year. This position is eligible for bonus and stock options. To learn more about Omeros, please visit www.omeros.com.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Omeros is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age, marital status, or any other factor determined to be unlawful by federal, state, or local statutes.

It is our policy to provide reasonable accommodation to anyone with a disability who needs assistance completing the job application process. If you need assistance, you can either send an e-mail to hr@omeros.com or contact Omeros, asking for Human Resources, at (206) 676-5000.