ADVANCED BIO-LOGIC SOLUTIONS
Clinical Systems Manager
ADVANCED BIO-LOGIC SOLUTIONS, Thousand Oaks, California, United States, 91362
Description:
Fully REMOTE
Shift - Monday - Friday, West coast candidate preferred
Sit anywhere in the US
The Manager, Clinical Systems (IRT) will work with a cross-functional team of internal stakeholders (including but not limited to: Clinical Study Management, Supply Chain and Data Management functions) and technology suppliers to support the implementation and maintenance of interactive response technology (IRT) solutions to support a clinical trial. The Manager, Clinical Systems (IRT) will provide technical oversight to ensure that IRT solutions adhere to the study protocol, industry regulations / best practices as well as company policies, procedures and guidelines.
Basic Qualifications:
Doctorate Degree OR Master's Degree and 2 years of IRT experience OR Bachelor's Degree and 4-5 years of IRT experience, clinical experience OR Associate's degree and 10 years of IRT experience OR High school diploma/GED and 12 years of IRT experience
Preferred Qualifications:
5+ years focused on IRT experience
Bachelor’s Degree in life science, computer science, engineering, business or related discipline
4+ years of experience in clinical operations, clinical supply chain or clinical systems management
Experience implementing clinical systems, such as IRT and eCOA
Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution
Detail-oriented and able to manage many projects simultaneously
Excellent documentation and communication skills
Meeting management and facilitation skills
Vendor management experience
Excellent time management and organization skills in a timeline-driven environment
Sound problem resolution, judgment, and decision-making abilities
Work well in a team-based environment with minimal supervision
Top 3 Must Have Skill Sets:
Technical expertise in IRT systems, management of projects and stakeholders, comfort managing documentation in a regulated environment
Fully REMOTE
Shift - Monday - Friday, West coast candidate preferred
Sit anywhere in the US
The Manager, Clinical Systems (IRT) will work with a cross-functional team of internal stakeholders (including but not limited to: Clinical Study Management, Supply Chain and Data Management functions) and technology suppliers to support the implementation and maintenance of interactive response technology (IRT) solutions to support a clinical trial. The Manager, Clinical Systems (IRT) will provide technical oversight to ensure that IRT solutions adhere to the study protocol, industry regulations / best practices as well as company policies, procedures and guidelines.
Basic Qualifications:
Doctorate Degree OR Master's Degree and 2 years of IRT experience OR Bachelor's Degree and 4-5 years of IRT experience, clinical experience OR Associate's degree and 10 years of IRT experience OR High school diploma/GED and 12 years of IRT experience
Preferred Qualifications:
5+ years focused on IRT experience
Bachelor’s Degree in life science, computer science, engineering, business or related discipline
4+ years of experience in clinical operations, clinical supply chain or clinical systems management
Experience implementing clinical systems, such as IRT and eCOA
Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution
Detail-oriented and able to manage many projects simultaneously
Excellent documentation and communication skills
Meeting management and facilitation skills
Vendor management experience
Excellent time management and organization skills in a timeline-driven environment
Sound problem resolution, judgment, and decision-making abilities
Work well in a team-based environment with minimal supervision
Top 3 Must Have Skill Sets:
Technical expertise in IRT systems, management of projects and stakeholders, comfort managing documentation in a regulated environment