Clinical Trial Manager

Omeros•Seattle, WA

69d•Onsite

About The Position

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. Good things are happening at Omeros! Come join our Clinical Operations Group! Who is Omeros? 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.

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
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.

Nice To Haves

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

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