Technical Project Manager II -IRT

Y-Prime, LLC; Malvern (Chester County); On-site; USD 110,000 - 140,000; Full time

Job summary

YPrime, LLC is seeking a Technical Project Manager II to lead the design and delivery of IRT solutions for clinical trials in Malvern, PA. You will collaborate with sponsors and SMEs to translate study protocols into system designs and oversee builds, testing, and launches with a highly consultative approach.

You will guide studies within the IRT platform, ensuring scalable, effective solutions aligned with trial objectives, while mentoring junior team members and coordinating milestones.

Qualifications

• Bachelor's degree or equivalent in a related field or experience.
• Foundational knowledge of SDLC principles.
• Experience in biotech/pharmaceutical or CRO industry preferred.
• Experience with SaaS delivery and systems supporting clinical trials.

Responsibilities

• Identify, document, and communicate system build requirements across the project team.
• Ensure consistent SDLC implementation across the project.
• Design basic studies based on protocol and client requests.
• Review configuration of base systems to avoid unnecessary custom code.
• Capture functional requirements in SRD and related documents.
• Translate functional requirements into technical specs for programmers.
• Lead ad-hoc testing of requirements in development environment.
• Support study validation and ensure documentation completeness.

Skills

IRT knowledge

Verbal and written communication

Attention to detail

Time management

Creative problem solving

Ownership and proactivity

Education

Bachelor's degree or equivalent

Tools

MS Office

SQL Server

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Technical Project Manager II -IRT

IRT Delivery Full Time Malvern, PA, US

About YPrime:

At YPrime, we pioneer solutions that streamline the clinical trial journey, increasing certainty from study design to data lock. With a foundation built on decades of industry insight and expertise, we are inspired by the life-altering outcomes unlocked by clinical trials. Our dedication to quality is pivotal in propelling the groundbreaking endeavors of our partners, researchers, and investigators. With a technology platform that enables speed, flexibility, and certainty for large and emerging pharma companies alike, we provide eConsent, eCOA, IRT, and patient engagement solutions that solve with certainty in clinical research.

About the Role:

As a Technical Project Manager, you'll lead the design and delivery of IRT solutions for clinical trials. Partnering with sponsors and internal subject matter experts, you'll gather requirements, translate study protocols into system designs, and guide studies through build, testing, and launch. This is a highly consultative role that combines project leadership, solution design, and problem-solving. You'll help shape how each study operates within the IRT platform, ensuring solutions are scalable, effective, and aligned with trial objectives.

Responsibilities:

• Ensure all requirements for system build are identified, documented, and communicated across the project team
• Consistent implementation of Software Development Life Cycle (SDLC)
• Responsible for the technical design of basic studies based on protocol, client requests and experience
• Review and support configuration of basic systems; understand the capabilities of base product to ensure custom code is not created inadvertently
• Ensures all functional requirements are captured in Systems Requirements Document (SRD) and other applicable system requirements documents
• Group functionalities and requirements that are similar together, and approach the design holistically
• Translates functional requirements into technical specifications for programmers
• Leads team in ad-hoc testing of requirements in development environment
• Ensures delivery of a clean study through validation environment
• Objectively review and approve system documentation and specifications as required
• Ensure documentation completeness and compliance of all YPrime SOPs and WIs
• Support system validation through the timely triaging of defects
• Demonstrates software prototypes for customers
• Assist in mentoring configuration specialists, if applicable
• Sets and tracks project milestones related to technical delivery; manages and accounts for unforeseen delays, then realigns schedules and expectations as needed.
• Communicates and coordinates project milestones with internal team
• Assist in mentoring more junior Technical Project Managers
• Assist in project scoping and change control processes, including revision management
• Adopts new processes and skills with minimal to no managerial oversight
• Responsible for the technical design of intermediate studies and system changes based on protocol, client requests and experience
• Review and support configuration of intermediate systems
• Research defect record frequency by type and proposes methods to reduce defect records, if applicable
• Works independently with YPrime team members to rectify UAT issues
• Work with cross-functional groups at YPrime to help develop, implement and document standards
• Uses past experiences and advanced knowledge of the system to strategically plan and mitigate risk
• Support audit preparation and activities as expected
• Perform other related duties as required

Skills:

• Comfort working with IRT
• Excellent verbal and written communication skills
• Exceptional focus on detail
• Time management and organizational skills
• Creative problem-solving ability
• Sense of ownership and proactivity

Education & Experience:

• Bachelor's degree in a related field or equivalent experience, preferred
• Proficient in MS Office applications required, database querying experience preferred (SQL Server)
• Foundational knowledge of the principles of SDLC required
• Experience in biotech/pharmaceutical or the CRO industry preferred
• Experience with Scrum Software Development is considered a plus
• Experience with SaaS delivery is considered a plus
• Experience with software systems in support of clinical trials