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NYSE American:CYBN
Cboe CA:CYBN

NYSE American:CYBN
Cboe CA:CYBN

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Home-Based Remote (Eastern Standard Time Zone)

CLINICAL MONITORING MANAGER (2 ROLES AVAILABLE)

Position Summary

The Manager, Clinical Monitoring supports global clinical trial operations in conducting and overseeing clinical site management and monitoring activities performed by us or an outsourcing partner. This role may conduct Clinical Monitoring visits or oversight visits for assigned studies. The Manager will support the development of processes, procedures, and tools/templates related to monitoring and site management activities. 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. This growth provides numerous opportunities for advancement and development, making it an exciting time to join our team. 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
  • With direction from Clinical Operations leadership, implement the strategy for in-house, regional monitoring activities on assigned studies, applying a risk-based approach when indicated. Studies may be managed internally or by the Clinical Research Organization (CRO).
  • Lead monitoring activities on assigned studies. This can include reviewing protocols, Case Report Forms (CRF) and completion guidelines, study manuals, and other related documents.
  • Author or review the Clinical Monitoring Plan in collaboration with the Clinical Operations Lead and ensure Clinical Research Associate (CRA) compliance with the current plan.
  • Manage the CRA monitoring visit schedule for each assigned study ensuring visit frequency and scheduled time on site aligns with risk-based indicators and site metrics.
  • Review and finalize visit reports in accordance with study timelines and monitoring plans. Follow up with CRO Lead/CRAs regarding outstanding trip reports and follow-up letters.
  • Track the status of action items and queries.
  • Maintain, and/or act on metrics related to CRA performance or site status.
  • Support the Clinical Operations Lead and/or CRO in implementing site corrective actions related to issues identified during monitoring activities.
  • Track and report to study team and leaders on compliance, trends and metrics related to monitoring and site management.
  • Support electronic Trial Master File (TMF) set-up, maintenance, ongoing quality review, and final reconciliation of study documents as needed.
  • With direction from the Clinical Operations Lead, manage the monitoring oversight strategy, including risk-based approaches, to assess the quality and compliance of CRO on assigned studies.
  • Manage or conduct monitoring oversight visits (MOVs) with CRO CRAs to assess compliance with the protocol and Clinical Monitoring Plan and document the visit’s results.
  • Review monitoring visit reports from CRO CRAs and escalate monitoring trends or findings to the Clinical Operations Lead.
  • Conduct or participate in Clinical Monitoring visits for our studies.
  • Mentors and provides leadership and direction to the CRA team members on study-related questions from start-up through closure.
  • Ensure adequate resourcing for CRAs on assigned studies; work with the CRO to plan for CRA re-assignment or acquisition of additional resources.
  • Escalate any study-related issues or impacts on deliverables, as appropriate, to the Clinical Operations Lead.
  • Support CRAs, study teams, and Quality with responses to audits or inspections.
  • Aid in developing and revising procedures promoting increased efficiency and quality of deliverables. May contribute to the development of standard operating procedures and other procedural documents.
  • May conduct monitoring assessment or CRO oversight visits as needed.
  • May participate in Interviews for proposed CRAs.
  • Support development and manage Clinical Monitoring budget requirements for assigned studies.
  • Perform review of site invoices related to assigned clinical trials.
  • Other duties as assigned.
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 in relation to the preparation of clinical trial documents
  • Excellent negotiation skills and a tactful approach that leads to high value on services obtained and outcomes achieved.
  • Demonstrated leadership skills.
  • Good judge of risks and a keen ability to analyze options and manage outcomes.
  • Well-versed with the latest trends in the clinical trial industry.
  • Commitment to working independently with minimal supervision.
  • Commitment to handling confidential information with discretion.
Education And Experience
  • Bachelor of Science in biological sciences or related discipline with 5+ years of relevant experience working in the biotechnology/pharmaceutical industry. Experience in Neurological indications is preferred.
  • Demonstrated critical thinking, root cause analysis and problem-solving to support CRAs with identifying site process failures; experience assisting CRA teams in developing corrective and preventative actions to bring sites into compliance.
  • Demonstrated understanding and application of Good Clinical Practices (GCP), International Council for Harmonization (ICH) Guidelines and regulatory requirements. Experience complying with safety standards and respecting privacy and confidentiality.
  • In-depth experience with cross-functional drug development with prior regulatory inspection experience is preferred.
  • Experienced and skilled in eTMF setup, maintenance/management and close-out.
  • Monitoring experience in startup, execution and close-out activities related to clinical studies; experience using risk-based monitoring processes is preferred.
  • Previous experience as a Lead CRA, Trial Manager, or equivalent is preferred.
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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