Remote Biopharma IRT System Lead (SK27345)

Contract: 1 Year (Renewable)
Job Title: IRT System Designer or IRT Lead/Systems Designer I
Job ID: 27345
Pay Rate: Up to $42/hr. W2

100% remote role

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

• The IRT Lead partners with internal team members to ensure the study protocol necessities are represented in Statement of Work (SOW) and Study Design Requirement documents.
• Collaborate with team members to ensure various IRT integrations are properly designed.
• He or she is accountable to work with the IRT vendor to ensure that study design, amendments, and timelines are successfully achieved.
• Experience with authoring IRT Requirements
• Experience with interpreting and incorporating protocol needs IRT into study documents
• Experience with authoring User Acceptance Test (UAT) scripts based on the details included in the study protocol, input from the study team, and Study Design Requirements.
• Support live studies where protocol amendments, questions, or escalations may need to be addressed. The Lead will be responsible for collaborating with the team and the IRT vendor to determine next steps.
• Expected to share IRT technical expertise with the study team, future study teams, and department to ensure lessons learned and standards are continuously improved and implemented.
• Participate in department and cross department initiatives to ensure the clinical trial experience continues to improve
• The Lead must have strong communication, team building, excellent problem-solving, critical thinking skills in order to provide the team an optimal IRT system.
• Serve as an IRT subject matter expert in the various interactions with the study team, IRT vendor, and department team members.
• Ensure IRT best practices, standards, and common data standards are incorporated into the study build and live study maintenance.
• Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), and to functional quality standard. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development.

Qualifications

• IRT = Interactive Response Technology (also known as IxRS, IWRS, RTSM)
o Software used for Clinical Trials (not the same as RAVE/EDC)
• Pharma companies with an IRT group
• IRT Vendors (Cenduit (IQVIA), Endpoint, Calyx, BioClinica, 4G, Suvoda)
• Actual CRAs would NOT be a good fit for this position
• Need candidates with IRT Specification writing experience
o IRT Requirements Analyst, IRT Project Manager

1) What hours and days will this person be working? We are open to US Business Hours (~8am-5pm) either PST, CST or EST
2) What 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
3) 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)
4) 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
5) 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.
6) Is any testing required for this role? No specialized testing is required beyond what is standard for employment with
7) 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)