United States
Be Structured Technology Group
Y-Prime, LLC
Technical Project Manager II -IRT
United States
Malvern, Pennsylvania, United States
SQL
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
- Proficient in MS Office applications required, database querying experience preferred (SQL Server)
- Foundational knowledge of the principles of SDLC required
- Experience with software systems in support of clinical trials
- Experience in IRT is required
Education & Experience
- Bachelor's degree in a related field or equivalent experience, preferred
- 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
- Technical management experience a plus
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