Clinical Trial Manager

Clinical Trial Manager

The 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.

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.

OMS
1029, 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 OMS
906), 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 OMS
527, 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.

• 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 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…