Project Manager - eCOA

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 eCOA Project Manager will lead and oversee the planning, execution, and successful delivery of projects. This role works with cross-functional teams, managing project schedules, and ensures that all project objectives are met on time and within budget. The Project Manager will be responsible for maintaining comprehensive project documentation and utilizing project management software to track progress and mitigate risks. They will serve as the primary point of contact for stakeholders, facilitating clear communication and alignment throughout the project life cycle.

Ultimately, this position aims to drive project development from initiation through closure, ensuring quality outcomes that support organizational goals.

Responsibilities:

• Leading a cross-functional project team to deliver software solutions that streamline the clinical trial process for clients
• Successfully delivering client projects centered on YPrime software applications in accordance with all YPrime SOPs, work instructions, and other processes or procedures
• Acting as primary point of contact for the client from contract award through system deactivation and archival; leading status meetings, tracking all open issues or questions, and providing status updates as required
• Overseeing the software solution design to meet project requirements based on the clinical protocol, proposal, and discussions with the client
• Facilitating internal and external specification review meetings while updating system requirements as required
• Managing schedule and scope for all projects; tracking all tasks required to deliver systems on-time for client user acceptance testing (UAT)
• Ensuring client satisfaction throughout the project build and maintenance phase, working with customer care, YPrime management, and internal departments as required
• Effectively managing projects on time and within budget
• Reviewing and approving system documentation and specifications to ensure documentation completeness and compliance of all YPrime SOPs and work instructions
• Providing support to system users in multiple countries via the telephone and email if required
• Traveling to client sites to attend meetings and leading training sessions if applicable
• Participating in client audits and quality-related tasks for assigned projects(s) as required
• Keeping up to date with company changes, industry, and technology trends while making suggestions that could affect the greater YPrime business or the Operations team

Skills:

• Excellent verbal and written communication skills
• Exceptional focus on customer service and passion working in a customer-facing role
• Interpersonal
• Time management and organizational skills
• Analytical reasoning skills
• Creative problem-solving ability
• Strong work ethic
• Sense of ownership and pro-activity
• Follow-through
• Ability to stay positive

Education & Experience:

• Bachelor's degree in related field or equivalent experience
• Foundational knowledge of the principals of SDLC required
• Project Management / Product Management related certifications preferred (PMP, CAPM, PgMP, etc.)
• Proficient in MS Office applications required, database querying experience preferred but not required (SQL Server)
• Experience utilizing ticketing systems preferred
• Experience working with project management tools preferred
• Experience with eClinical systems and clinical trials preferred