Clinical Trial Manager

Us: Eupraxia•Seattle, WA

About The Position

About Us: Eupraxia is a clinical-stage biotechnology company focused on developing locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. DiffuSphere™, a proprietary, polymer-based micro-sphere technology, is designed to facilitate targeted drug delivery of both existing and novel drugs. The technology is designed to support an extended duration of effect and delivery of drugs in a hyper-localized fashion, targeting only the tissues that physicians want to treat. We believe the potential for fewer adverse events may be achieved through the precision targeting and the stable and flat delivery of the active ingredient when using the DiffuSphere™ technology, versus the peaks and troughs seen with more traditional drug delivery methods. The precision of Eupraxia's DiffuSphere™ technology platform has the potential to augment and transform existing FDA-approved drugs to improve their safety, tolerability, efficacy and duration of effect. The potential uses in therapeutic areas may go beyond pain and inflammatory gastrointestinal disease, where Eupraxia currently is developing advanced treatments, also to be applicable in oncology, infectious disease and other critical disease areas. Eupraxia's EP-104GI is currently in a Phase 1b/2 trial, the RESOLVE trial, for the treatment of EoE. EP-104GI is administered as an injection into the esophageal wall, providing local delivery of drug. This is a unique treatment approach for EoE. Eupraxia also recently completed a Phase 2b clinical trial (SPRINGBOARD) of EP-104IAR for the treatment of pain due to knee osteoarthritis. The trial met its primary endpoint and three of the four secondary endpoints. In addition, Eupraxia is developing a pipeline of later and earlier-stage long-acting formulations. Potential pipeline indications include candidates for other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs. For further details about Eupraxia, please visit the Company's website at: www.eupraxiapharma.com . Scope As our Clinical Trial Manager (CTM) you will be primarily responsible for the operational management and oversight of Eupraxia clinical studies. You will also help us build our clinical operational infrastructure and teams. Travel Requirement: Must be willing to travel domestically and internationally (approximately 20%), as needed Reports to: SVP, Clinical Operations

Requirements

Bachelor’s degree or equivalent in life sciences
At least 6 years of clinical operations experience in the pharmaceutical industry with significant knowledge of GCP/ICH guidelines and the clinical development process
At least 1 year of experience managing industry sponsored pharmaceutical clinical trials as a sponsor employee
Ability to plan, organize and conduct clinical trials with minimum oversight
Experience leading, managing, or mentoring clinical operational staff and cross-functional teams
Significant experience managing CROs and other vendors and assessing performance and finances (e.g., invoice review, change order management, and budget reforecasting)
Strong interpersonal, communication (written and verbal), and organizational skills
Able to motivate a team to work effectively
Able to solve problems under pressure

Responsibilities

Ensuring studies are carried out according to the study protocol, SOPs, and ICH/GCP guidelines/regulations and study specific manuals and procedures
Independently developing the trial’s timelines, budgets, key deliverables, and risk/mitigation strategies
Leading the development of trial materials (e.g., protocol, informed consent forms, case report forms (CRF), CRF completion guidelines, monitoring guidelines, site initiation visit materials, site tools and worksheets, product administration guidelines)
Planning and leading study team meetings
Managing, mentoring, and training clinical operational staff
Leading the identification and engagement of CROs and other third-party study vendors
Managing and improving performance of third party vendors and field CRAs to ensure compliance with study protocol and consistency with scope of work; identify areas of concern and escalate as appropriate
Identifying, selecting, and monitoring performance of investigational sites; ensuring accurate and timely site visit reports
Developing and maintaining good working relationships with investigators and study staff
Negotiating and managing the budgets and payments for investigative sites
Tracking and ensuring optimization of site startup activities and activation, subject enrollment, data collection, and study closeout
Ensuring completeness and accuracy of Trial Master File
Managing investigational product release packages and investigational product accountability
Performing clinical data review of data listings and summary tables, including query generation
Other duties as assigned