Skip to main content

This job has expired

You will need to login before you can apply for a job.

Clinical Trial Manager/Sr. Clinical Trial Manager

Employer
Omeros Corporation
Location
Seattle
Start date
May 15, 2019

View more

Discipline
Clinical, Clinical Trials
Required Education
Bachelors Degree
Position Type
Full time

Job Details

Omeros is seeking a Clinical Trial Manager/Sr Clinical Trial Manager to join the Clinical Development Team. As a member of our team, you'll work closely with internal team members and vendors as well as clinical study sites ensuring that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals and budgets. You'll have responsibility for managing the operational aspects of clinical trials including managing clinical operations personnel.

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?

  • Managing the operational aspects of clinical trials
  • Managing Clinical Operations personnel
  • Managing the study project plan, including timeline, budget and resources
  • Participates in protocol, CRF and strategy development, Clinical Study Report preparation, and NDA submission
  • Preparing metrics and updates
  • Proactively identifying potential study issues/risks and recommending/implementing solutions
CRO/vendor activities including:
  • Participating in and facilitating the CRO/vendor selection process for outsourced activities
  • Managing CRO interactions including sponsor oversight of operational functional activities (study management, monitoring, site management, project master files)
  • Working with the CRO to develop and revise scope of service agreements, budgets, plans, and detailed timelines ensuring that performance expectations are met
  • Preparing, reviewing, and approving study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual and CRF Completions Guidelines)
  • M anaging clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
  • Participating in the development, review and implementation of departmental SOPs and processes
  • Recommending and implementing innovative process ideas to positively impact clinical trials management
  • Organizing and managing internal team meetings, investigator meetings and other trial-specific meetings; serving as a liaison and resource for investigational sites
  • Reviewing site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments
  • Participating in the selection, training and evaluation of study personnel (contract and internal) to insure the efficient operation of the function
  • Serving as a liaison and resource for investigational sites
You'll need a 4-year degree with a related degree in a Life Science and

2+ years of related clinical trial management experience, with a minimum of 1 year of supervisory experience.

Additional experience we are seeking includes:
  • Experience in interactions with outside CROs and other vendors
  • Experience providing clinical operations expertise to clinical development in a specified project or project area
As our ideal candidate, you'll need the following skills and knowledge:
  • Familiarity with the advanced concepts of clinical research
  • Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines
  • Ability to provide clinical operations expertise to clinical development in specified product areas and projects
  • The ability to deal with time demands, incomplete information or unexpected events
  • Demonstrated analytical and problem-solving skills; attention to detail
  • Excellent interpersonal skills with the ability to build and maintain positive relationships with management, peers, and subordinates
  • The ability to work effectively in a team/matrix environment
  • Excellent written and verbal communication skills
  • Presentation skills including the ability to develop and present varied and unique ideas
  • This role will require overnight travel approximately 10% of the time; during peak times overnight travel will be 50% or greater
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.

Company

At Omeros, we are proud of our innovative and cutting-edge science. Our world-class team has achieved scientific advances that no other group has been able to accomplish, delivering wholly new classes of therapeutics to benefit patients. We let science lead the way.

From our foundation of groundbreaking science, we continue to build and advance a deep and diverse pipeline of small-molecule and protein therapeutics. We are not interested in developing “me-too” products; instead, we are focused on tackling challenging diseases and disorders with significant unmet medical needs. The result is an exciting pipeline of first-in-class drugs with new mechanisms of action that target previously untapped receptors and enzymes.

The Omeros team is exceptionally talented, passionate, collaborative and diverse. We hire smart, creative and hard-working people who want to play a meaningful part in building a preeminent biopharmaceutical company. We come from all corners of the globe, bringing unique abilities and experiences together to provide hope to patients and their families.

Company info
Website
Phone
206.676.5000
Location
201 Elliott Avenue West
Seattle
Washington
98119
US

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert