What are the responsibilities and job description for the Clinical Systems Manager position at Advanced Bio-Logic Solutions Corp?
Description:
Fully REMOTE
Shift - Monday - Friday, any time zone however west coast based in preferred but not required
Sit anywhere in the US
Successful Candidate:
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:
Top 3 Must Have Skill Sets:
Technical expertise in IRT systems, management of projects and stakeholders, comfort managing documentation in a regulated environment
Pay Rate between $74 - $85/Hr on W2 based on experience.
"This posting is for Contingent Worker, not an FTE"
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
- IRT (Interactive response technologies) / RTSM (Randomization and Trial Supply Management) system experience required
- Pharma or Biotech or IRT supplier experience required
- 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 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
Pay Rate between $74 - $85/Hr on W2 based on experience.
"This posting is for Contingent Worker, not an FTE"
Salary : $74 - $85
