Risk Based Quality Manager at Neurocrine Biosciences, leading RBQM activities for clinical studies and managing study level Risk Management Plans.

Requirements

BA/BS in life sciences or related discipline or RN
6+ years of related industry experience, including experience in drug development, clinical operations or RBQM/Risk Management
Ability to interpret clinical trial data and analytics to identify risks and support operational decision-making
Strong organizational and project management skills, with the ability to manage multiple priorities across studies
Ability to work effectively in a matrixed, cross-functional environment and build productive relationships with study team members
Demonstrated ability to follow established processes while identifying practical opportunities for improvement
Proven ability to quickly learn new information and communicate requirements to the appropriate individuals
Effective verbal and written communication skills, including the ability to clearly communicate observations, risks, and recommendations
Solid understanding of Risk Based Quality Management principles and their application within Clinical Operations
Working knowledge of FDA regulations, ICH guidelines, and GCP requirements relevant to clinical trial conduct, oversight, and RBQM

Benefits

Requirements

BA/BS in life sciences or related discipline or RN

6+ years of related industry experience, including experience in drug development, clinical operations or RBQM/Risk Management

Ability to interpret clinical trial data and analytics to identify risks and support operational decision-making

Strong organizational and project management skills, with the ability to manage multiple priorities across studies

Ability to work effectively in a matrixed, cross-functional environment and build productive relationships with study team members

Demonstrated ability to follow established processes while identifying practical opportunities for improvement

Proven ability to quickly learn new information and communicate requirements to the appropriate individuals

Effective verbal and written communication skills, including the ability to clearly communicate observations, risks, and recommendations

Solid understanding of Risk Based Quality Management principles and their application within Clinical Operations

Working knowledge of FDA regulations, ICH guidelines, and GCP requirements relevant to clinical trial conduct, oversight, and RBQM