Clinical Trial Manager
W2 Contract
Salary Range: $166,400 - $176,800 per year
Location: Redwood City, CA - Hybrid Role
Job Summary:
As a Clinical Trial Manager, you will be responsible for Contract Research Organization (CRO) oversight and execution of clinical studies. This role is a unique opportunity for an experienced Clinical Operations Professional with technical expertise in managing Phase I-III clinical trials in an industry setting and a strong knowledge of clinical operations, Good Clinical Practice (GCP), and US Food and Drug Administration (FDA) regulatory requirements. Clinical operations experience in oncology is required for this role.
Requirements and Qualifications:
- BS or MS degree with 5+ years of clinical operations experience in the pharmaceutical or biotech industry, preferably the majority 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
- Able to travel (~25%)
- Experience in working with cooperative group studies and investigator-sponsored trials is preferred.
- Experience in global clinical trial operations is desired.
- Knowledge of APAC regulations is highly desired.
Desired Skills and Experience
Clinical operations, oncology, drug development, clinical trial, FDA Regulations, ICH Guidelines, GCPs, vendor management, APAC regulations, travel
Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.
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