Clinical Trial Associate/Sr. Clinical Trial Associate (CTA/SCTA)

The Company
enGene (NASDAQ: ENGN) is a late-stage biotechnology company mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, whose lead program detalimogene voraplasmidis being evaluated in an ongoing pivotal study for patients with non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis) who are unresponsive. Detalimogne voraplasmid was developed using enGene’s proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA. For more information, visit enGene.com.

Role

Clinical Trial Associate/Sr. Clinical Trial Associate (CTA/SCTA) will support the day-to-day operations of assigned studies and ensures deliverables are met in terms of quality, compliance, and timelines. Ability to support multifunctional teams with internal stakeholders, CROs, and external vendors is critical for this role. The position will report to Sr Clinical Project Manager. This role may work collaboratively on one trial or across several trials to support clinical operations activities.

Essential Duties And Responsibilities

• Support the day-to-day study execution activities of assigned clinical trial(s) to ensure deliverables are met in all phases of trial including study feasibility assessment and site start up activities
• Develop and manage study trackers and provide metrics as needed
• Organize and prepare study files including those related to study tracking and reporting and submit to the Trial Master File within established guidelines
• Contribute to the development and review of critical study documents, such as study protocol, eCRF, ICF, etc
• Work with key stakeholders to oversee the timely development and finalization of key study plans and manuals
• Support and document study level Sponsor Oversight of outsourced clinical activities
• Support inspection readiness and provide support to sites to prepare for clinical audits/inspections
• Communicate study-status and issues to ensure timely decision-making by senior management
• Provide input on operational considerations to protocol development
  
  
  
  

Skills

• History of successfully supporting study teams with internal key stakeholders, outside vendors, CROs, and central/specialty labs
• Demonstrated experience with EDC, IRT and eTMF platforms
• Supports in developing training and/or informational material and presenting to both internal and external stakeholders
• Support study management in management of schedule, budget, communication, resources, and quality
• Ability to analyze, evaluate and prioritize key issues and problems, and subsequently seek-out and recommend possible solutions and mitigation strategies before escalation
• Ability to independently problem-solve or propose innovative solutions and to work independently with minimal direction/oversight and within a team structure
• Positive and “can do” approach
  
  
  
  

Required Experience And Qualifications

• Bachelor’s degree required
• 2 years of experience in a clinical trial experience in the CRO, pharmaceutical or biotech industry
• Minimum of 2 years support of clinical trial activities (start-up through close-out), preferably in a global environment
• Understanding of drug development
• Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
  
  
  
  

enGene USA Inc. is an Equal Opportunity Employer:

All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. At enGene USA Inc., we are building a community of intelligent and passionate team members that share our Vision, Mission, and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.