Clinical Trial Manager
W2 Contract-to-Hire
Salary Range: $156,000 - $176,800 per year
Location: Redwood City, CA - Hybrid Role
Job Summary:
This role offers a unique opportunity for an experienced Clinical Operations Professional with technical expertise in managing Phase I-III clinical trials within an industry setting and a solid understanding of clinical operations, Good Clinical Practice (GCP), and FDA regulatory requirements. In this position, you will be responsible for overseeing Contract Research Organizations (CROs) and ensuring the successful execution of our clinical studies. Oncology experience is preferred.
Requirements and Qualifications:
- BS or MS degree; 5+ years of clinical operations experience in the pharmaceutical or biotech industry, preferably in oncology drug development
- Hands-on experience in running early-stage clinical trials within an industry environment
- Strong working knowledge of FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
- Experience in the selection of CROs and vendors and management of external resources.
- A demonstrable record of strong vendor management and teamwork
- Direct experience in managing clinical CROs
- Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
- Excellent written and verbal communication skills
- Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary team is crucial.
- Able to travel (~25%)
- Experience in working with cooperative group studies and investigator-sponsored trials is preferred.
- Experience in global clinical trial operations is desirable.
- Knowledge of APAC regulations is highly desired.
Desired Skills and Experience
Clinical trial, Oncology, drug development, ICH Guidelines, FDA Regulations, GCP, CRO, vendor management, travel, APAC regulations
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