Clinical Trial Manager/Sr. Clinical Trial Manager

Location
Seattle
Posted
Aug 13, 2019
Ref
1689
Required Education
Associate Degree
Position Type
Full time
The Clinical Trial Manager/ Sr. Clinical Trials 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 Development Group!

Who is Omeros?

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases and disorders of the central nervous system.

The company's drug product OMIDRIA® (phenylephrine and ketorolac injection) 1% / 0.3% is marketed in the U.S. for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.

Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington's disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.

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
  • 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)
  • 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.
  • 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.
  • 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.
If you have the skills, knowledge and experience we are looking for, we'd love to hear from you!

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 hr@omeros.com or contact Omeros, asking for Human Resources, at (206) 676-5000.