Clinical Trial Manager

Clinical Trial ManagerThe Clinical Trial Manager (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. This position is responsible for ensuring achievement of Omeros' project goals and objectives. This person may have line management responsibilities. This person is able and willing to perform all duties or functions of subordinates.Good things are happening at Omeros!Come join our Clinical Operations Group!Omeros is an innovative biotechnology company that discovers and develops first-in-class protein and small-molecule therapeutics for both large-market and orphan indications, with a focus on the treatment of complement-mediated diseases, cancers, and addictive or compulsive disorders. Omeros' lead complement inhibitor YARTEMLEA® (narsoplimab-wuug), which targets the lectin pathway's effector enzyme MASP-2, is FDA-approved and commercially available in the U.S. for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adult and pediatric patients two years of age and older. OMS1029, Omeros' long-acting MASP-2 inhibitor, has successfully completed Phase 1 clinical trials.Under an asset purchase and licensing agreement, Novo Nordisk acquired global rights to zaltenibart (formerly OMS906), an inhibitor of MASP-3, the alternative pathway's key activator, which is in clinical development for PNH and other alternative pathway indications, along with associated intellectual property and related assets. Omeros' pipeline also includes OMS527, a phosphodiesterase 7 inhibitor in clinical development for cocaine use disorder, which is fully funded by the National Institute on Drug Abuse, and a growing portfolio of novel recombinant antibodies targeting multidrug-resistant organisms and novel molecular and cellular therapeutic programs for oncology.What are your job responsibilities?Manages the operational aspects of clinical trialsManages Clinical Operations personnelManages the study project plan, including timeline, budget, and resourcesParticipates in protocol, CRF and strategy development, Clinical Study Report preparation, NDA submission, as appropriatePrepares metrics and updates for management, as assignedProactively identifies potential study issues/risks and recommends/implements solutionsParticipates in and facilitates CRO/vendor selection process for outsourced activitiesManages 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 metPrepares 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 regulationsParticipates in the development, review and implementation of departmental SOPs and processesRecommends and implements innovative process ideas to positively impact clinical trials managementOrganizes and manages internal team meetings, investigator meetings and other trial-specific meetingsServes as a liaison and resource for investigational sitesReviews site study documents (informed consent template and study tools/worksheets), investigator contracts, and site paymentsParticipates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the functionPerforms some or all of the Duties and Responsibilities outlined for Senior Clinical Research Associate, as neededWhat experience and education do you need?A 4-year degree from a university with a related degree in a Life ScienceA minimum of 5 years of related clinical trial management experience with a minimum of 2 years of supervisory experienceExperience in interactions with outside vendors, e.g., CROs and other vendorsFamiliar with advanced concepts of clinical research and able to work effectively in a team/matrix environmentKnowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelinesAble to deal with time demands, incomplete information or unexpected eventsAble to provide clinical operations expertise to clinical development in a specified product areas and projectsAble to travel approximately 10% overnight (50% or greater during peak times)Behavioral Competencies Required:Must possess excellent interpersonal skillsMust have the ability to build and maintain positive relationships with management, peers, and subordinatesExcellent written and verbal skillsMust be able to develop and present varied and unique ideas.Develops and provides challenging yet appropriate assignments and communicates progress toward objectives and goalsMust 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 lawsResponsibilities include interviewing, hiring, and training employees; planning, assigning, directing work, and appraising performanceThis position will also supervise work in a matrix organization.Physical Demands Required:May encounter prolonged period of sittingThe employee may frequently be performing repetitive movements such as typing on a keypad or using a mouseThe employee may climb bend, reach, push, pull, balance, stoop, kneel, or crouchThe employee must on occasion lift and/or move up to 25 pounds.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 this position is ($125,000-$150,000). 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 incentive and stock options. To learn more about Omeros, please visit 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 View email address on click.appcast.io InfoJob Identification 2102Posting Date 09/01/2026, 09:21 PMJob Schedule Full timeLocations Seattle, WA, United States