What are the responsibilities and job description for the Technical Project Manager - IRT position at YPrime?
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: The Technical Project Manager will lead and oversee complex technology projects from initiation through completion, ensuring alignment with organizational goals and stakeholder expectations. This role requires working well with cross-functional teams, coordinating resources, and maintaining clear communication channels to deliver projects on time and within budget. The successful candidate will translate technical requirements into actionable project plans, balancing technical constraints with business needs. They will be responsible for risk management, issue resolution, and continuous process improvement throughout the project life cycle. Ultimately, this position drives the successful delivery of innovative information systems solutions that enhance operational efficiency and support strategic 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, RTSM
- 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 in IRT / eCOA / a related technology is required