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
Seniority level
Not Applicable
Employment type
Full-time
Job function
Finance and Consulting
Industries
Financial Services and Hospitals and Health Care
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