Clinical Trial Manager/Sr. Clinical Trials Manager, Early Stage / Phase I
The Sr. Clinical Trials Manager (CTM), Early Stage / Phase I 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 Omeros Clinical 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.
What are your 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
Education, Experience, Knowledge, & Skills Required:
- A 4-year degree from a university with a related degree in a Life Science
- For a Sr. CTM, 8+ years of related clinical trial management experience with a minimum of 2 years of supervisory experience is needed; for a CTM, 6+ years of related clinical trial management experience with a minimum of 2 years of supervisory experience is needed
- Experience in Early Stage/ Phase 1 CTM/Sr CTM experience
- Experience interacting 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
- Must possess excellent interpersonal skills
- Excellent written and verbal communication skills
- Display strong analytical and problem-solving skills
- Ability to provide clinical operations expertise to clinical development in a specified product areas and projects
Behavioral Competencies Required:
- Ability to build and maintain positive relationships with management, peers, and subordinates
- Ability to develop and present varied and unique ideas
- Ability to develop and provide challenging yet appropriate assignments and communicate progress toward objectives and goals
- Ability to deal with time demands, incomplete information or unexpected events
- 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
- Ability to travel 10% overnight (50% 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 CTM is $118,000 to $140,000 per year. For the Sr CTM, the wage scale is $134,000 to $152,000. Salaries will be determined based on knowledge, skills, education, and experience relevant to the role. Employees are offered medical, dental, vision and life insurance and a 401k plan with a company match. Employees accrue three weeks of vacation and 80 hours of sick time on an annual basis and receive ten 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.
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@example.com or contact Omeros, asking for Human Resources, at (206) 676-5000