The posting
Job Description
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.
Good things are happening at Omeros!
Come join our Clinical Operations Group!
About Omeros Corporation
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 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 aged two years and older. OMS1029, Omeros’ long-acting MASP-2 inhibitor, has successfully completed Phase 1 clinical trials.
Under a recently announced 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. For more information about Omeros and its programs, visit www.omeros.com.
What are your job 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
What experience and education do you need?
- 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 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 www.omeros.com.
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 [email protected]
