Clinical Study Manager
Today, the biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the trial process takes nearly a decade and frequently costs $100M+. And the problem is only getting worse.
At TrialSpark, we don’t believe it has to be this way. Through technology and a new operational model, we’re reimagining how clinical trials are run, with the mission of bringing new treatments to patients faster.
We do this by partnering with physicians to enable them to run clinical trials within their existing practices. By providing the technology platform, equipment, and staffing, TrialSpark alleviates the operational burden of clinical research, enabling physicians to focus on what they do best -- patient care. And by bringing clinical research to physician practices, TrialSpark is enabling access for the 98% of patients who are never exposed to clinical trial opportunities.
About the role
The Clinical Study Manager (CSM) role is critical to the success of the studies TrialSpark is engaged in. The CSM oversees the clinical execution of studies, from feasibility to closeout. They are responsible for high-quality execution across our sites, including training of staff, engagement with PIs, and working closely with sponsors.
This role is a linchpin of our clinical execution, and thus requires someone with extensive knowledge of clinical research, and a strong ability to partner with others across Ops, QA, and sponsors to deliver a high-quality study.
- Oversee the clinical execution of Phase II - IV research studies, where TrialSpark is either providing a subset of sites, or managing the entire end-to-end study.
- Work with site-level CRC staff, other Ops teams, and QA to execute studies in an efficient, high-quality way.
- Ensure full clinical readiness for new studies, including oversight of CRC and PI training, site feasibility, source building, and startup.
- Ensure adherence to protocols, SOPs, and GCP across sites, including carefully tracking KPIs to ensure excellence.
- Partner closely with sponsors to understand study objectives and deliver a high-quality study that meets their goals.
- Constantly re-assess how we are executing clinical research, challenging assumptions and questioning the status quo.
- 5+ years in clinical research industry, including 2+ years in a study management role (Clinical Trial Manager, Senior CRA, etc.)
- Experience across multiple therapeutic areas; expertise in gastroenterology, dermatology, or respiratory preferred.
- A strong understanding of site-level quality and GCP, including best practices for drug management, regulatory, source data, clinical supplies, etc.
- Experience implementing protocols across clinical sites, including training of CRCs, PIs, and other staff.
- Strong written and oral communicator, including ability to engage in complex clinical discussions with sponsors and PIs.
- Bachelor’s degree, B.S. preferred; R.N. or other advanced degree a plus.
- An earnest desire to re-think the way clinical research is done.
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.