IRT System Designer / EDC Builder (IRT)

Position Title: IRT System Designer / EDC Builder (IRT)

Location: Remote

Contract Period: 12 Months / 1 Year

Shift Timings: Mon - Fri, 08:00 AM - 05:00 PM EST/CST/PST

MUST HAVE 5+ YEARS OF PHARMACEUTICAL/MEDICAL DEVICE/LIFE SCIENCES/HEALTHCARE INDUSTRY EXP.

IRT System Designer II

Location: Prefer someone close to one of the Client offices (Irvine, NJ or Lake County)

Length of assignment: 1 year

What hours and days will this person be working? We are open to US Business Hours (~8am-5pm) either PST, CST or EST

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

• Required Skill 1: Experience in the biopharma industry/clinical research with knowledge of ICH/GCP practices
• Required Skill 2: Experience drafting and updating IRT specification requirements documentation
• Required Skill 3: Experience in project management of IRT systems (from initial build to study closure)
• Required Skill 4: Experience writing IRT system test scripts and facilitating/leading UAT testing efforts
• 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.

Is any testing required for this role? No specialized testing is required beyond what is standard for employment with Client

Does this position offer the ability to work remotely on a regular basis or is it an on-site role? If remote opportunity exists, what are the options (i.e. 1 day remote, 4 days on-site)? 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 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 w…