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Manager Clinical Systems (JP8326)

Raleigh, North Carolina · Biotech/Pharmaceutical
Job Title:  Manager Clinical Systems (JP8326)
Location: North Carolina (100% REMOTE)
Employment Type:  Contract
Business Unit: CSAR Global Systems IRT
Duration: 1+ years (with likely extensions)
Posting Date: 12/1/20
 
 
3 Key Consulting is hiring a Manager Clinical Systems for a consulting engagement with our direct client, a leading global biopharmaceutical company.
 
Job 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
 
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 include:
  • 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.
 
 
Why is the Position Open?
Backfill.
 
 
Top Must-Have Skill Sets:
  • 2-3 years of experience specifically in IRT/IVRS/RTSM/IXRS - either at a vendor, biotech or Pharma company.  (Must have been part of a build or project managed the build. This is an important skill set and there will be no opportunity for training.  Candidate must be very skilled in this area. Candidates without this skill set/experience will be rejected. (Interactive response technology)
  • This person will most likely come from a background in Business Analysis, Clinical Supply, Project Management (2-3 years of experience)
  • Clinical Trial experience (2-3 years of experience)
 
 
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
 
 
Employee Value Proposition:
Chance to join fast paced dynamic team where the candidates where be challenged and have a direct positive impact on patients' lives.
 
Red Flags:
Does not have ALL THREE top required skill sets. These are non-negotiable. This candidate must be fully qualified for this role or they will be rejected.
 
 
Interview process:
Video Skype Panel Interview
 
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
 
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 

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