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Clinical Systems Manager- (IRT) Interactive response technologies-remote (JP10408)
Thousand Oaks, CALIFORNIA · Biotech/PharmaceuticalJob Title: Clinical Systems Manager- (IRT) Interactive response technologies-remote (JP10408)
Location: Thousand Oaks, CA - Virtual site (100% Remote)
Employment Type: Contract
Business Unit: CSAR Global Systems - IRT
Duration: 12 months with likely extensions
Job posting date: 06/07/2022
Note: Remote
3 Key Consulting is hiring a Clinical Systems Manager for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Qualified candidate must have experience in designing IRT systems based on clinical protocol and have managed IRT through SDLC (Software development lifecycle).
Ideal Candidate:
Job Summary:
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.
Preferred Qualifications:
Day-To-Day Responsibilities:
Interview Process:
Video call through WebEx
We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.
Location: Thousand Oaks, CA - Virtual site (100% Remote)
Employment Type: Contract
Business Unit: CSAR Global Systems - IRT
Duration: 12 months with likely extensions
Job posting date: 06/07/2022
Note: Remote
3 Key Consulting is hiring a Clinical Systems Manager for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Qualified candidate must have experience in designing IRT systems based on clinical protocol and have managed IRT through SDLC (Software development lifecycle).
Ideal Candidate:
- IRT - Interactive response technologies
- Pharma or Biotech or supplier experience required
- Must have experience designing or maintaining IRT systems for clinical trials
- Candidate will be working remote - open to US Time Zone
- Negotiation with external vendors, management of projects and people, familiarity with documentation in a regulated environment
Job Summary:
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.
Preferred Qualifications:
- 5+ years of 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
Day-To-Day 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
Interview Process:
Video call through WebEx
We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.
Regards,
3KC Talent Acquisition Team