Clinical Software Implementation Specialist

Title21 Health Solutions, a leading provider of Health and Life Science data management solutions, is seeking a Clinical Software Implementation Specialist.The Clinical Software Implementation Specialist (CSIS) is responsible for providing business domain and technological expertise in support of the configuration and deployment of complex data management solutions into the Cell and Gene Therapy, immunotherapy, regenerative medicine and BMT domains. This position seeks a professional experienced in the role of Medical Laboratory Technologist, BMT Nurse, BMT Case Management Nurse\Coordinator, or similar role, who is looking for a new and innovative way to use their experience and expertise. An ideal candidate for this position is passionate about technology and has experience in the Cellular and Gene Therapy/Processing, Regenerative Medicine or immunotherapy, or BMT programs in the IND or Standard of Care settings. This position is responsible for the successful deployment and customer support of a Laboratory Manufacturing and Information System focused in the Cellular Therapy/Manufacturing and Regenerative Medicine space.

CSIS Candidate Background

The ideal candidate will have several years (3-7) of lab experience in one or more of the above areas, and will have then transitioned to the Lab/Clinical Information Technology team, wherein they will have developed skills and experience (3-5 years) in the planning, requirements development, design, configuration, deployment, validation and training of clinical based software systems, whether developed in-house or implementing a vendor’s system.

Responsibilities

  • Deliver complete customer delight!
  • Gain and demonstrate mastery of the Title21 Health Solutions system, including performing business and requirements analysis, workshop facilitation, system configuration and implementation, user acceptance testing, validation, and post go-live support activities.
  • Gain and demonstrate deep understanding and familiarity with the target customer domain(s) including, clinical, laboratory workflows, compliance and regulations (FACT, CLIA, CAP, FDA, etc.), Quality Management, Inventory/ Supplies Management, Training/Learning Management and Content Management.
  • Perform analysis of customer’s business requirements/workflows/processes/expectations and translate and configure into Title21 Health Solutions product. Identify gaps early in deployment cycle.
  • Assist customer’s project team in understanding the Title21 system capabilities, and steering the team to ideal solutions that map their requirements into the software.
  • Troubleshooting and resolving customer issues. Provide consultative telephone and email support.
  • Configure, deploy, validate and review validations of the software solution to meet customer requirements.
  • Communicate and present in a simple and effective manner the capabilities and functionality of Title21 Health Solutions as it is relevant to the customer’s domain and objectives.
  • Lead meetings (both face-to-face and remote) as part of the gathering and development of requirements.
  • Develop and managing all aspects of the requirements documentation at all levels of the deployment process (Customer Requirements (PRD), Data Dictionaries, Workflow Requirements, Test Requirements, Traceability Matrices, Interface specifications, etc.)
  • Support sales team with demonstrations and technical/industry expertise throughout the sales process. Help translate the key customer benefits to the market (Webinars, sales calls, etc.)
  • Conducting all levels of training at customer site and Title21 locations.
  • Deliver assignments on time and of high quality.
  • Feedback customer issues and work with the development group to resolve customer needs.
  • Participate in user groups with webinars, conference calls, tech talks, etc.

Minimum Required Skill Set

  • Demonstrated domain expertise in any of the following areas
    • Cellular and/or Gene Therapy Manufacturing in the Research/Clinical/Laboratory setting
    • BMT Stem Cell Labs, BMT Clinical Case Management
    • Immunotherapy or Regenerative Medicine Cell processing and manufacturing
    • Cord Blood banking
    • Other cell processing/manufacturing technologies.
  • Demonstrated ability to learn quickly and add value immediately in a fast paced environment.
  • Demonstrated ability to work as both a team member and as an individual contributor.
  • Excellent time management skills.
  • Excellent verbal, public speaking, and written communication skills. Ability to effectively document results.
  • Demonstrated ability to deliver clear, concise instructions, communicates difficult concepts simply and effectively, and maintains professional presentation skills.
  • Highly detailed oriented with extremely good follow-up.
  • Excellent interpersonal skills with a genuine enthusiasm in the aforementioned fields.
  • Strong familiarity with Windows/PCs environments.
  • Strong initiative and ability to thrive in self-directed work teams.
  • Strong critical thinker with the ability to learn new systems, synthesize information and formulate recommendations.

Required Experience

  • Minimum 3-7 years’ relevant work experience in any one or more of the following roles:
    • Medical Laboratory Technologist (MT)
    • RN/Nurse Coordinator in Clinical BMT Programs
    • Cell Laboratory Supervisor
    • Lab IT Technologist
    • Lab IT Business\Systems Analyst
    • Research Associate
  • Cell or Gene Lab environment experience
  • Working knowledge and familiarity with pertinent standards and regulations FACT, CLIA, AABB, CAP, FDA (21CFR Part 1271), Public Health Services Act (Section 361) Regulations.
  • Strong technical skills and familiarity with technology.
  • Experience as a user of complex clinical and lab computer applications.

 Highly Desirable Experience

  • Experience working within, or implementing relevant regulations and standards as mentioned above.
  • Experience in training customers on Clinical Software Applications.
  • Hands-on experience troubleshooting and analyzing system issues.

Personal Traits

  • Ability to work independently and self-starting.
  • Enjoy working on a team with enthusiastic, talented professionals; being a team player and enjoying a collaborative environment is essential.
  • Ability to be agile in a high growth, fast-paced environment.
  • Willingness to learn, grow and take on more responsibilities.
  • Desire to learn and master the Title21 software systems.
  • Self-starter, reliable, conscientious, hard-working, customer-focused team member.

Education Requirements

  • Relevant 4-year college degree in the Nursing/Medical Technology Sciences.

Position Type

Full-Time Employment; Non-Exempt

Travel

Required; approximately 20%

Locations

Scottsdale, Arizona

Pittsburgh, Pennsylvania

Pleasanton, California

Compensation

Title21 Health Solutions provides a highly competitive compensation and benefits package including:

  • Medical Plan
  • Dental/Vision plan
  • 401(k) with company match and 100% Immediate Vesting
  • Paid Holiday/Vacation/Personal days
  • Life Insurance Plan

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