Clinical Trial Manager
San Francisco Bay Area
Salary: $130,000-$160,000 +15% bonus + pre-IPO equity
This company is founded and led by some of the industries brightest with their C suite coming from the likes of Merck. Much of their leadership were crucial to the development of Keytruda. This company is one that has potential well beyond just one blockbuster drug due to their proprietary drug discovery platform. This platform is rooted in a new way to characterize protein that has led them to much more accurate drug targets. What makes this exciting is that it not only has applications in Oncology, but Neurology and Immunology as well.
With nearly $800 million in funding they have a cash runway for years to come, and their current pipeline is robust. In addition to the phase 3 you will be working on they have 11 other indication in development.
The Clinical Trial Manager will be responsible for:
- Collaborate with external vendors, including CROs, laboratories, and imaging providers, to ensure timely and effective deliverables.
- Build and maintain strong relationships with investigators, study coordinators, and site personnel to support patient recruitment and retention.
- Monitor and assess trial progress, identify risks, and implement corrective measures to achieve study goals and maintain timelines.
- Ensure regulatory compliance with FDA guidelines, ICH-GCP standards, and other relevant regulations.
- Oversee all aspects of global clinical trial management, ensuring high-quality study data is delivered on time and within budget.
- Lead trial start-up activities, collaborating with Clinical Operations teams for site selection, feasibility assessments, and documentation.
- Develop and execute operational strategies for the management of oncology clinical trials.
- Support site initiation, training, and monitoring to guarantee compliance with protocols, regulatory standards, and ICH-GCP guidelines.
- Collaborate with cross-functional teams, including data management, clinical scientists, regulatory groups, and investigators, to uphold operational excellence.
- Contribute to the creation and review of key study documents such as protocols, informed consent forms, case report forms (CRFs), and standard operating procedures (SOPs).
- Maintain detailed study files, including the study master file and site file oversight, and conduct regular reviews.
The Clinical Trial Manager should have the following qualifications:
- In-depth knowledge of clinical trial regulations, guidelines, and best practices, including ICH-GCP and FDA requirements, specific to oncology research
- Demonstrated experience in managing and executing clinical trials from start-up to closeout
- Proficiency in using Veeva clinical trial management systems (CTMS)
- Understanding of oncology therapeutic areas, including familiarity with oncology treatment modalities, disease progression, and related medical terminology.
Benefits:
- A competitive salary with benefits.
- A real hands-on opportunity to gain a high degree of commercial exposure.
- Working with highly-talented and dedicated colleagues in a fast-growing company that combines a focus
on cutting-edge science with commercial delivery
If you are interested in the Clinical Trial Manager role, then please don't wait to apply.