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Senior Manager, Trial Operations
Xenon Pharmaceuticals Inc.Senior Manager in Trial Operations managing clinical studies at Xenon Pharmaceuticals, a neuroscience-focused biopharmaceutical company. Overseeing trial management and ensuring compliance with regulatory standards.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Provide clinical trial management leadership for multiple Phase 1 and 4 studies, across therapeutic areas
- Collaborate with cross-functional team members to ensure highly integrated plans and documents for clinical trials
- Develop, propose, and manage plans for assigned studies and activities
- Lead the preparation of Requests for Proposals (RFPs) in collaboration with other internal team members
- Manage contracted service providers to deliver against the contracts
- Lead the selection of qualified investigators and study sites
- Review and oversee study budgets and invoices to ensure vendors are invoicing in accordance with their contracts
- Develop and manage study timeline and study metrics cross-functionally
- Conduct risk assessments, mitigation strategies and contingency planning
- Communicate with internal/external teams to proactively recognize challenges
- Actively participate in all aspects of clinical trial operations, including coordination, writing, review and/or finalization of clinical trial protocols and consent forms
- Train and mentor new staff or peer mentorship of new hires
- Oversee adherence to applicable regulations and standards of clinical practice
Requirements
What you’ll need- A minimum bachelor’s degree in a scientific discipline and/or other healthcare designation (e.g., RN)
- A minimum of 5-8 years clinical project/study management experience within the pharmaceutical and/or biotechnology/biopharmaceutical industry or at a CRO
- Ability to lead cross-functional team through all activities in the full clinical study life cycle
- Experience in Phase I and Phase IV study conduct preferred
- Strong vendor management skills and experience managing outsourced work
- A good understanding of all phases of the drug development process and the interdependencies between Clinical and other functional areas
- Demonstrated ability to successfully manage and deliver on critical milestones in clinical trials
- Strong knowledge and understanding of ICH/GCP and US and Canadian regulatory environments
- Excellent oral and written communication skills
- Strong interpersonal skills and ability to foster strong collaborative relationships with team members
- Exceptional attention to detail and excellent organizational skills
- Ability to thrive in a dynamic and fast-paced environment
Benefits
Comp & perks- Our Total Rewards program includes base salary, target bonus, and stock options
- Full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs
- Employee Assistance Program
- Travel insurance
- Retirement savings programs with company matching contributions
- Time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown
- Expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial managementstudy managementvendor managementrisk assessmentstudy budgetingclinical trial protocolsconsent formsstudy timeline managementclinical study life cycledrug development process
Soft Skills
leadershipcommunicationinterpersonal skillsorganizational skillsattention to detailcollaborationmentorshipproblem-solvingadaptabilitycritical thinking
Certifications
bachelor's degree in scientific disciplinehealthcare designation (e.g., RN)