Clinical Systems Manager

Advanced Bio-Logic Solutions Corp; Thousand Oaks (CA); On-site; USD 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a Manager for Clinical Systems specializing in IRT solutions. This fully remote role involves overseeing the implementation and management of interactive response technology systems to support clinical trials. The ideal candidate will possess extensive experience in IRT systems, data analytics, and project management, ensuring adherence to industry regulations and best practices. Join a dynamic team and contribute to impactful clinical research while enjoying the flexibility of a remote work environment. If you thrive in a fast-paced, collaborative setting and have a passion for improving clinical operations, this opportunity is perfect for you.

Qualifications

• Experience with IRT systems and data analytics is essential.
• Strong project management and clear communication skills required.

Responsibilities

• Manage implementation and maintenance of IRT solutions for clinical trials.
• Provide technical oversight to ensure compliance with protocols and regulations.

Skills

Data analytics

IRT system experience

Project management

Clear communication

Vendor management

Education

Doctorate Degree

Master's Degree

Bachelor's Degree

Associate's Degree

High school diploma/GED

Tools

Tableau

Job description

Description:

Please ask candidates these pre screening questions. Provide answer on resumes.

1. Have you experience analyzing IRT data through Tableau or other software?
2. Have you supported implementation of system-to-system data integrations through the SDLC (Software development lifecycle)?
3. On which IRT platforms do you have experience with?

Fully REMOTE

• Shift - Monday - Friday, any time zone however west coast based in preferred but not required
• Sit anywhere in the US

Successful Candidate:

• Experience understanding how systems communicate with one another through integrations as they relate to IRT systems
• Data analytics / Tableau experience a plus
• IRT (Interactive response technologies) / RTSM (Randomization and Trial Supply Management) system experience required
• Pharma or Biotech or supplier experience required; previous experience a plus
• Must have experience designing or maintaining IRT systems for clinical trials
• Negotiation with external vendors, management of projects and people, familiarity with documentation in a regulated environment
• Clear communicator
• Positive disposition
• Used to a white glove role and able to support IRT users internally and externally.
• Knows their stuff and can demonstrate through experience. Lead projects against tight timelines.
• 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
• Master's Degree and 2 years of IRT experience
• Bachelor's Degree and 4-5 years of IRT experience, clinical experience
• Associate's degree and 10 years of IRT experience
• 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:

• Real work experience outside of school environment
• Technical expertise in IRT systems and data (Analyzing data, building studies, support)
• Familiarity with documentation in a regulated environment
• Management of projects and stakeholders

Pay Rate between $74 - $85/Hr on W2 based on experience.

This posting is for Contingent Worker, not an FTE.