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Manager, Clinical Systems (IRT)

Thousand Oaks, CA

Top 3 Must Have Skill Sets:

1. 2-3 years of experience specifically in IRT/IVRS/RTSM/IXRS - either at a vendor, biotech or Pharma company. ***When discussing these technologies with the candidates, they must have been part of a build or project managed the build. This is an important skill set that the managers do not have time to train on so they must be very skilled in this area. Candidates without this skill set/experience will be rejected. (Interactive response technology)
2. This person will most likely come from a background in Business Analysis, Clinical Supply, Project Management (2-3 years of experience)
3. Clinical Trial experience (2-3 years of experience)

Description:

*IRT - Interactive response technologies
*Pharma or Biotech or supplier experience required
*Must have clinical trial experience
*Candidate will be we working remote - Ideally PST - open to US Time Zone
*Please submit candidate at market rate for review
- Please do not submit any candidates that interviewed for AMAGJP00007971 -

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.

Responsibilities:
• Serve as the champion and consultant for most efficient and effective IRT design as needed per study protocol
• Lead and facilitate system requirements gathering meetings with clinical study teams and IRT supplier contacts
• Design and oversee the development of study-specific IRT technical documents
• Document issues and risks, and implement mitigation plans in partnership with study team and technology supplier PM
• Identify and track study-related technical issues to resolution
• Closely manage project-related timelines and associated activities

Basic Qualifications:
• Doctorate Degree
OR
• Master's Degree and 3 years of IRT experience
OR
• Bachelor's Degree and 5 years of IRT experience
OR
• Associate degree and 10 years of IRT experience
OR
• High school diploma/GED and 12 years of IRT experience

Preferred Qualifications:
• 5+ years of IRT experience and / or a clinical supply chain discipline (supply chain management, distribution, packaging, labeling, etc.)
• 4+ years of experience in clinical operations 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
• Bachelor’s Degree in life science, computer science, engineering, business or related discipline
• Detail-oriented and able to manage many projects simultaneously
• Excellent documentation and communication skills
• Meeting management and facilitation skills
• Supplier 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

"This posting is for Contingent Worker, not an FTE"

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