Technical Project Manager II -IRT

Y-Prime, LLC•Malvern, PA

About The Position

YPrime is seeking a Technical Project Manager to lead the design and delivery of IRT solutions for clinical trials. The role partners with sponsors and internal subject matter experts to gather requirements, translate study protocols into system designs, and guide studies through build, testing, and launch. It combines project leadership, solution design, and problem-solving, shaping how each study operates within the IRT platform and ensuring solutions are scalable, effective, and aligned with trial objectives.

Requirements

Comfort working with IRT.
Excellent verbal and written communication skills.
Exceptional attention to detail.
Time-management and organizational skills.
Creative problem-solving ability.
Ownership and proactivity.
Proficiency in MS Office applications.
Foundational knowledge of SDLC principles.
Experience with software systems supporting clinical trials.
Experience in IRT.

Nice To Haves

Bachelor's degree in a related field or equivalent experience.
Database querying experience, preferably with SQL Server.
Experience in the biotech, pharmaceutical, or CRO industry.
Experience with Scrum software development.
Experience with SaaS delivery.
Technical management experience.

Responsibilities

Identify, document, and communicate all system-build requirements across the project team.
Apply the Software Development Life Cycle (SDLC) consistently.
Design basic studies based on protocols, client requests, and experience.
Review and support configuration of basic systems, using knowledge of base-product capabilities to avoid unnecessary custom code.
Ensure functional requirements are captured in the Systems Requirements Document (SRD) and other applicable requirements documents.
Group similar functionalities and requirements and take a holistic approach to design.
Translate functional requirements into technical specifications for programmers.
Lead ad-hoc testing of requirements in the development environment.
Ensure delivery of a clean study through the validation environment.
Objectively review and approve system documentation and specifications as required.
Ensure documentation is complete and complies with YPrime SOPs and work instructions.
Support system validation by triaging defects promptly.
Demonstrate software prototypes to customers.
Mentor configuration specialists, if applicable.
Set and track technical delivery milestones, manage unforeseen delays, and realign schedules and expectations as needed.
Communicate and coordinate project milestones with the internal team.
Assist in mentoring junior Technical Project Managers.
Assist with project scoping and change-control processes, including revision management.
Adopt new processes and skills with minimal or no managerial oversight.
Design intermediate studies and system changes based on protocols, client requests, and experience.
Review and support configuration of intermediate systems.
Research defect-record frequency by type and propose ways to reduce defect records, if applicable.
Work independently with YPrime team members to resolve UAT issues.
Collaborate with cross-functional YPrime groups to develop, implement, and document standards.
Use past experience and advanced system knowledge to plan strategically and mitigate risk.
Support audit preparation and activities as expected.
Perform other related duties as required.