IRT Systems designer

IRT System Designer II

Locations: (Prefers someone onsite)

Irvine, CA 92612 .

Lake County, IL 60064

Florham Park, NJ 07932

US Business Hours (~8am-5pm) either PST, CST or EST

Length of assignment: 1 year

Does this position offer the ability to work remotely on a regular basis or is it an on-site role? Yes, we are open to fully remote depending on the candidate’s location (there are currently no travel requirements)

Other notable details about the environment from the hiring manager about this role This is an urgent need as we need to hire asap – we need to bring in candidates who have relevant experience as we will be expecting this person to be proficiently working without a large ramp up/training period

2What are the top 5 skills/requirements this person is required have?

a. Required Skill 1: Experience in the biopharma industry/clinical research with knowledge of ICH/GCP practices

b. Required Skill 2: Experience drafting and updating IRT specification requirements documentation

c. Required Skill 3: Experience in project management of IRT systems (from initial build to study closure)

d. Required Skill 4: Experience writing IRT system test scripts and facilitating/leading UAT testing efforts

e. Required Skill 5: Ability to manage competing priorities and management of multiple ongoing assignments at one time

What years of experience, education, and/or certification is required?

Bachelor’s degree and 3+ years of IRT experience (exception/consideration can be made for 2 years’ experience if candidate is coming from an IRT Vendor)

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? PMP certification. General knowledge of EDC and technical system integrations

What is the environment that this person will be working in (i.e. group setting vs individual role)? This individual will be part of our IRT System Designers group but will be leading IRT study activities individually. They will be the IRT representative leading a clinical study team through IRT activities.

What positions/background experience do you feel are successful in this role Background in Clinical Research and experience in the IRT field (specifically in writing IRT Specification documentation)

Experience Level = 3-5 Years

Job Description

The Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences.

Responsibilities

• Actively participates in the development of common data standards and ensures systems designs comply with the standards, as well as with associated protocol requirements. Ensures that the design team utilizes standards
• Establishes and maintains methodology used by the team to design and develop clinical trial systems, benchmarking against industry standards. Ensures that systems are specified to optimize on functionality, end user experience, and data flow. Ensures that the design team meets these expectations
• Ensures that TA- and program-level consistency is achieved by the design team
• Accountable for the on-time design and delivery of new clinical systems, integrations between systems, as well any required changes to clinical systems (e.g., EDC, IRT, ePRO). Utilizes project management tools to track study progress and plan work. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions
• Interacts with and influences DSS and cross-functional team members to achieve program and study objectives. Ensures that assigned work product is synchronized with upstream and downstream dependencies
• Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Client's Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development
• Responsible for coaching and mentoring members of the team, as well as contributes to their skill development
• Leads DSS and cross-functional innovation and process improvement initiatives

Qualifications

• Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Masters preferred.
• Must have 5+ years of clinical technology experience (e.g. EDC, IRT, ePRO) or 7+ years of experience in a similar technical role or in a clinical development role. Experience with common industry design and development tools required.
• In-depth knowledge of clinical trial process.
• In-depth knowledge of CDASH and SDTM.
• Demonstrated performance as a key contributor to initiatives and advancement of the organization.
• Demonstrated ability to influence others without direct authority.
• Demonstrated ability to successfully coach / mentor in a matrixed environment.
• Demonstrated effective communication skills and analytical skills.

Position: IRT System Designer or IRT Lead

• IRT = Interactive Response Technology (also known as IxRS, IWRS, RTSM)
• Software used for Clinical Trials (not the same as RAVE/EDC)
• Pharma companies with an IRT group
• Actual CRAs would NOT be a good fit for this position
• Need candidates with IRT Specification writing experience
• IRT Requirements Analyst, IRT Project Manager