Clinical Trial Manager
2 weeks ago
US - Remote
Contract to Hire
Must have Sponsor Experience
Our clients success is driven by our people. We are dedicated to attracting individuals who share our vision to improve human health by putting patients first.
But it's not just about what we do, it's how we do it. That's why we hire creative and courageous individuals who support one another and are not afraid to try new ideas. Our culture reflects our values which are brought to life every day by the following characteristics:
SELFLESS - Patients come first and we're in this together. Our environment is collaborative and we measure success through our collective accomplishments.
COURAGEOUS - Transformational innovation leads to Client treatments. "Tried-and-true" won't produce breakthroughs for patients - a pioneering spirit, willingness to accept certain risks and to try new approaches. Each employee and functional team is expected to bring their heart, experience and trust on our journey.
IMAGINATIVE - We value and encourage a creative approach across all aspects of our work. We challenge ourselves and each other to think beyond what is known and approach our work through a lens of continuous improvement.
JOYFUL - Humor and heart allow us to tackle the seriousness of our work. Excellence and fun are not at odds - we love what we do and enjoy the journey.
Position Overview:
The CTM will support the delivery of clinical study(ies), ensuring they are conducted on time, within budget, and of appropriate quality.
Responsibilities:
- Supports the successful execution of one or more clinical studies from study planning to close-out
- Participates in vendor selection and contracting. Oversees vendor performance, including review of vendor deliverables.
- Participates in the management of study finances, including review of vendor contracts, budgets, and invoices
- Participates in the development of study timelines, in coordination with study team and external parties. Manages trial according to agreed timelines
- Ensures clinical trials are conducted in compliance with Good Clinical Practice, local regulations, study protocols, and SOPs
- Identifies potential risks to timelines, budgets, or quality and participates in establishing and overseeing mitigation strategies with the cross functional team
- Participates in site and vendor selection activities and Trial Master File management
- Leads the development of fit-for-purpose operational plans (e.g., Monitoring Plan, TMF Plan) and ensures trial activities are conducted in accordance with agreed plans
- Maintains strong relationships with CROs, vendors, and investigative sites
- Works in partnership with key internal functions including, but not limited to Finance, Legal, Regulatory, Biometrics, Clinical Development, and Medical Affairs
- Participates in SOP / process development and other department initiatives, as needed
Education and Experience
- Bachelor's degree in a scientific discipline required; master's degree or higher preferred
- At least 4 years' experience in clinical operations in biotech/pharma companies and/or CRO
- Experience with Phase 1-3 industry-sponsored clinical trials
- Experience with vendor and site selection and oversight
- Demonstrated experience working in Good Clinical Practice; experience with sponsor regulatory inspection(s) desired
- Working knowledge of data management, regulatory operations, and pharmacovigilance
- Experience with neuroscience, oncology, or rare disease clinical trials strongly preferred
- Demonstrated leadership to drive results that are needed to achieve company objectives in accord with culture and values - courageous, imaginative, selfless and joyful
- Strong written and verbal communication skills; excellent organizational skills
- Ability to work autonomously while seeking direction, as appropriate
- Good problem-solving skills and a strong sense of urgency
- Good interpersonal skills
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