Bayside Solutions
Clinical Trial Manager
Bayside Solutions, Fremont, California, us, 94537
Clinical Trial ManagerW2 ContractSalary Range:
$166,400 - $187,200 per yearLocation:
Redwood City, CA - Hybrid RoleJob 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. Oncology experience is preferred, and you may be required to travel up to 25% of the time.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 developmentHands-on experience in running early-stage clinical trials within an industry environmentStrong working knowledge of FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trialsExperience in selecting CROs, vendors, and management of external resources.A demonstrable record of strong vendor management and teamworkDirect experience in managing clinical CROsThrives 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 skillsAble to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary teamAble 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 ExperienceClinical trial, drug development, Oncology, Phase I-III, FDA, ICH Guidelines, GCP, vendor management, APAC regulations, travelBayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at .
$166,400 - $187,200 per yearLocation:
Redwood City, CA - Hybrid RoleJob 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. Oncology experience is preferred, and you may be required to travel up to 25% of the time.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 developmentHands-on experience in running early-stage clinical trials within an industry environmentStrong working knowledge of FDA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trialsExperience in selecting CROs, vendors, and management of external resources.A demonstrable record of strong vendor management and teamworkDirect experience in managing clinical CROsThrives 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 skillsAble to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary teamAble 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 ExperienceClinical trial, drug development, Oncology, Phase I-III, FDA, ICH Guidelines, GCP, vendor management, APAC regulations, travelBayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at .