Job title: Clinical Trial Manager

Reporting to: SVP of Clinical Operations

Location: Full Time or Contract; Seattle based

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

Primary 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

Job Qualifications and 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

How to Apply:
Please submit your CV and cover letter at link below.

While only short-listed candidates will be notified, we thank each applicant for their submission.

Job title: Clinical Research Associate

Reporting to: SVP of Clinical Operations

Location: Full Time; Seattle based

Scope:

As our Clinical Research Associate (CRA) you will be primarily responsible for the operational management and oversight of Eupraxia clinical study’s monitoring.

Travel requirement: Must be willing to travel domestically and internationally (approximately 20-25%), as needed

Primary Responsibilities:

• Assisting Clinical Trial Manager in ensuring trials are initiated efficiently, completed on time, within budget and conducted in compliance with SOPs, regulations, and ICH/GCP guidelines
• Assisting Clinical Trial Manager in managing CRO partners and other vendors
• Working closely with and providing training to CRO staff, study site staff, and field-based CRAs
• Overseeing, conducting, and/or co-monitoring site qualification, study initiation, interim monitoring, and close out visits and completing associated reports
• Developing and/or assisting in 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)
• Reviewing monitoring reports and monitoring visit letters written by CRO CRAs
• Driving CRO and trial sites with study startup activities, including IRB/IEC submissions and ensuring collection and review of required essential documents
• Creating, monitoring, and sharing key performance metrics with study teams
• Reviewing completed CRFs and data listings for accuracy, overseeing data discrepancy management, and performing associated training/retraining to site staff and CRAs as needed
• Developing strong and effective working relationships within Clinical Operations and other functional departments and CROs

Job Qualifications and Requirements:

• BS/BA in life sciences or related discipline
• 5+ years pharma/biopharma industry experience, preferably in a sponsor-side role
• 1+ years of active, independent, on-site monitoring experience for all types of visits
• Strong working knowledge of FDA and ICH/GCP regulations and guidelines
• Thorough knowledge of clinical monitoring procedures
• Strong interpersonal, communication (written and verbal), and organizational skills
• Excellent analytical and assessment skills, judgment, and problem-solving skills

How to Apply:
Please submit your CV and cover letter at link below.

While only short-listed candidates will be notified, we thank each applicant for their submission.