Clinical Trial Manager/Senior Manager
As a member of the Clinical Development 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?
- Participating 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)
- Managing 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
What experience and education do you need?
You’ll need a 4-year degree with a related degree in a Life Science and 5+ years of related clinical trial management experience, with a minimum of 2 years of supervisory experience.
Additional experience we are seeking includes the following experience:
- Experience in interactions with outside CROs and other vendors
- Familiarity with the advanced concepts of clinical research
- Knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines
- Experience providing clinical operations expertise to clinical development in a specified project or project area
What skills does our ideal candidate have?
As our ideal candidate, you’ll need the following skills and knowledge:
- 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
- The ability to develop and provide challenging yet appropriate assignments and effectively communicate progress toward objectives and goals
What else should you know?
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!