Senior Clinical Project Manager

enGene is a late-stage biotechnology company mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, whose lead program EG-70 is being evaluated in an ongoing pivotal study for patients with non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG). EG-70 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. enGene became a publicly traded company effective November 1, 2023, upon the completion of a business combination with Forbion European Acquisition Corporation, a special purpose acquisition company. For more information, visit enGene.com.

Role

enGene is seeking an experienced Senior level Clinical Project Manager (CPM) with an understanding of the clinical trial process, competency in CRO and trial management, strong organizational skills, and excellent collaboration and communication abilities. The successful candidate will join a fast-paced and highly innovative team dedicated to delivering clinical trials that meet the highest standards of scientific excellence.

As an integral member of the team, the Senior Clinical Project Manager will report to the VP of Clinical Development Operations and work closely with cross functional team members, clinical research organizations (CROs), and other vendors to ensure clinical trial execution is conducted in accordance with the protocol, SOPs, ICH/GCP/regulatory guidelines, and company goals while ensuring quality of study execution and timely delivery of trial milestones.

Essential Duties & Responsibilities

• Support the planning, implementation and execution of enGene’s clinical trials
• Responsible for communicating effectively with internal and external study personnel and in facilitating the activities associated with the successful clinical trial management and execution of global clinical programs
• Manage clinical operations trial activities on a day-to-day basis with the support of Operational Management
• Participate/facilitate internal project team meetings
• Manage and oversee activities at the CRO and other clinical vendors; monitor status and provide real-time updates to the management; facilitate communication between enGene and the Clinical CRO; and monitor CRO and vendor adherence to the scope of work
• Ensure all study activities are completed in accordance with country specific ICH GCP, health authority regulations and company SOPs
• Responsible for ongoing study communication and escalation of study-related issues as required
• Proactively identify, resolve and escalate issues that jeopardize study completion or study quality
• Identifies potential risks from study and site perspective and works with the team to assist in proactively resolving issues with CROs
• Contribute to the writing and development of clinical documents such as Protocols, Informed Consent Forms, Investigator Brochures, project plans, pharmacy manuals, study operational plans, study reports and annual reports; Assist in the development of clinical trial training materials, presentations and investigator meetings
• Manage recruitment and support tactics
• Ensure that tracking tools are implemented throughout the trials for the Clinical Operations teams
• Review of data management aspects of clinical trials
• Support clinical operations functions during audits
• Oversight of out-sourced clinical monitoring and visit reports
• Ensure oversight of the TMF appropriately throughout the trial, including periodic reviews
• Fully understand the need for and importance of being inspection ready and diligently follow Clinical Operations SOPs; identify communicate gaps
• Interface with other internal functions to coordinate relevant and timely exchange of information/materials to support clinical trials
• Support invoice and budget activities for clinical trials
• Support review of clinical trial agreements and budgets
• Participates in UAT for EDC/IRT
• May perform periodic visits to sites and/or CRO to assess progress of studies/protocol compliance
• Other duties and responsibilities as required
  
  
  
  

Skills

• Familiarity with ICG, GCP, and FDA requirements, as applicable, for clinical trial management
• Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment
• Ability to work within established timelines, in a fast-paced environment
• Excellent oral and written communication skills
• Excellent organizational and priority management skills
• Strong computer skills including knowledge of Microsoft Excel, Word, and Outlook
• Strong interpersonal skills and ability to influence without authority
• Strong analytical and problem-solving skills
  
  
  
  

Required Experience & Qualifications

• Bachelor's degree in science or related discipline required, advanced science degree (MS or equivalent) preferred
• 5+ years of prior experience managing clinical trials for or within the biotech or pharmaceutical industry, including direct oversight of CROs, monitoring of budget scope, clinical site monitoring, and knowledge of basic data management, biostatistics processes and pharmacovigilance
• Ability to understand and operationalize scientific concepts
• In-depth knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines is required
• Computer programs systems: Proficient with the following MS Office (Word, Excel, PowerPoint) Outlook or similar calendar system, familiarity with MS Project (or other similar systems), EDC systems (i.e. RAVE), CTMS
• Global experience preferred
• Experience with registration-enabling study preferred
• Prior gene therapy, oncology, urology experience is a bonus and not required