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NYSE American:CYBN
Cboe CA:CYBN

NYSE American:CYBN
Cboe CA:CYBN

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LOCATION: Home-Based Remote (Eastern Standard Time Zone)

MANAGER/DIRECTOR, CLINICAL SYSTEMS AND PROCESSES

Position Summary

The Manager/Director, Clinical Systems and Processes provides subject matter expertise and system support to ensure that the electronic Trial Master File (eTMF) is audit and inspection ready at all times. This role will support the implementation, maintenance, and operation of other clinical systems such as SharePoint, Smartsheet, eTMF and other systems, as required. They will ensure the eTMF and other clinical systems are managed in accordance with relevant regulations, ICH/GCP guidelines, and internal standard operating procedures. This position requires a high degree of professionalism, organization, and the ability to be resourceful and think fast.

About Cybin

We are a remote-based workplace that operates internationally and is growing daily. We work across multiple time zones and with various internal and external partners. Our core values are the backbone of our business and guide our hiring process: we are a team of disciplined, high-performing, and results-oriented people who strive for excellence in our execution. Our mission is to revolutionize mental healthcare by developing differentiated, next-generation therapeutics.

Objectives
  • Support process improvement initiatives, including new systems implementation, system configurations, and updates of centralized clinical operations systems.
  • Develop departmental policies, procedures, and training to increase efficiency and quality of deliverables.
  • Serve as system administrator for document management systems.
  • Provide training on system processes for internal and external stakeholders.
  • Serve as primary eTMF contact for all clinical studies, ensuring questions related to eTMF items are addressed within ten (10) regular business hours.
  • Serve as the Records Manager for the eTMF lifecycle by performing set-ups and quality reviews, ensuring all documents are accurately uploaded and properly indexed, improving compliance, and archiving.
  • Drive the creation of eTMF Plans and study-specific Master Lists to oversee the execution of study eTMF plans.
  • Ensure all clinical study documentation is collected, handled, transferred, stored and/or entered into our eTMF in accordance with our standard operating procedures, ICH-GCP guidelines, and global standards and requirements.
  • Report to the Clinical Operations Director and collaborate with the Clinical Operations Team to develop and maintain study eTMF Plans and Indexes.
  • Monitor and identify study-specific eTMF trends and communicate with Clinical Operations and/or other functional teams as needed.
  • Lead eTMF kick-off meetings for new studies, ensuring roles are assigned as per standard operating procedures and relevant study plans.
  • Review and update existing eTMF user roles bi-annually and as needed.
  • Apply knowledge of the DIA TMF reference model to revise and update study-specific Master List templates and Naming Conventions.
  • Liaise with study leads during inspection readiness activities to identify missing documents and develop a remediation strategy for obtaining them.
  • Support mock inspections and act as inspection eTMF subject matter expert for assigned studies.
  • Prepare for Inspection Readiness activities, including conducting eTMF gap analysis activities to ensure we maintain inspection-ready status at all times.
  • Act as part of the core inspection team and own key responsibilities, including document requests, access to the eTMF for the auditors and inspectors, and easy retrieval of clinical documents on request.
  • Contribute to the integrity, completeness, and accuracy of our eTMF systems.
  • Cooperatively and effectively work in a team environment, including meeting agreed-upon deadlines, prioritizing, and balancing work and projects from multiple sources.
  • Provide oversight to our Clinical Research Organization partner contracted to manage eTMF.
  • Assist in contract and budget review associated with vendor document management and review of associated invoices.
  • Assist the clinical operations team with activities outside of the eTMF by creating any user-friendly document formats for agendas, action items, timelines, or process workflows, as needed.
  • Handle special projects and initiatives as needed.
  • Other duties as required.
Competencies
  • Proficiency with Microsoft Office Suite
  • Excellent follow-up and follow-through skills
  • Excellent organizational, multitasking, and time management skills
  • Excellent attention to detail and problem-solving skills, including the ability to devise and implement practical solutions to resolve complex issues
  • Excellent written and verbal communication abilities and presentation skills
  • Commitment to working independently with minimal supervision
  • Commitment to handling confidential information with discretion
Education And Experience
  • Bachelor of Science with 5+ years of relevant experience in biotechnology/pharmaceutical industry
  • Experience with all phases of clinical trials to support required documentation and filing for clinical operation purposes
  • Proficiency with system configuration, administration, and troubleshooting of electronic document management systems and eTMF platforms such as Florence Healthcare, SharePoint, Smartsheet, etc.
  • Experience working with clinical documents, including ICH-GCP, FDA regulations and EMA directives
Physical Requirements
  • Prolonged periods sitting at a desk and working on a computer
  • Travel 1-2x per year
Benefits
  • Medical, Dental & Vision Coverage
  • Health Spending Account
  • Retirement Savings Plan
  • Internet and Mobile monthly stipend
  • Paid Time Off
  • Mandatory Office Closure December 25 – January 1 inclusive
Commitment to Diversity

As an Equal Opportunity Employer committed to meeting the needs of a multigenerational and multicultural workforce, Cybin Inc. recognizes that a diverse staff, reflective of our community, is an integral and welcome part of a successful and ethical business. We hire talent at all levels regardless of ethnicity, colour, national origin, age, religion, sexual orientation, gender identity or expression, family or parental status, veteran status, neurodiversity status, disability status, or any other basis protected by applicable law.

We are proud to provide accommodations during the recruitment process.  Should you require accommodation, please contact us at HR@cybin.com, and we will work with you to meet your accessibility needs.  We appreciate all applications however, only those candidates selected for an interview will be contacted.

Contact

If this position caught your eye, send us your resume! For consideration, include the job title and source where you found this position in the subject line of your email to HR@cybin.com.

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