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

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

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

Senior Manager, Trial Operations

Key skills