IRT Project Manager / Senior Manager
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
We’re looking for an exceptional IRT Project Manager / Senior Manager, to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world. This role can be based anywhere in the US.
The IRT Project Manager / Senior Manager is responsible for managing assigned IRT projects for our clients through all phases of the Software Development Life Cycle (including: design, development, deployment, and ongoing support & maintenance).
- Analyze the study protocol to understand the study needs
- Lead and facilitate system requirements gathering with clinical study teams and sponsors
- Oversee the successful development and validation of assigned IRT systems
- Participate in client meetings, manage project timelines, budgets, and related activities throughout the software development lifecycle
- Implement software changes or suggest necessary improvements to system operations and specifications
- Support and oversee User Acceptance Testing (UAT)
- Support and manage the training needs of the end-users for comprehensive user education
- Perform recurring budgetary review to ensure the project remains within scope
- Identify and advocate new technologies, tools, and processes to increase effectiveness of the group and services
- All other projects as assigned
EDUCATION, SKILLS & COMPETENCIES:
- Bachelor’s Degree (preferred)
- 3 - 7 + years' minimum experience in a client facing IRT Project Management role
- Strong experience with the concepts of IRT including: randomization, treatment assignment, resupply settings, blinding, and data privacy
- Experience in project management in an FDA regulated environment, preferably in a CRO and/or Bio/Pharmaceutical industry is preferred
- Knowledge of Biostatistical and Randomization methodologies is preferred
- Knowledge of the SDLC (Software Development Life Cycle)
- Working knowledge of FDA Guidance Documents and EU Directives; knowledge of ICG / GCP Regulations
- Experience with SQL a plus
- Experience with ePRO\eCOA a plus
Personal skills & behaviors:
- Excellent written and verbal communication skills
- Ability to multitask and work effectively in a fast-paced environment with changing priorities
- Excellent team player, collaborative and able negotiate effectively
- Excellent organizational and time-management skills, able prioritize work to meet deadlines
- Customer focused with a strong attention to detail
- Maintains a positive, results orientated work environment
At Premier Research, we are science-minded and heart-centered. Join us.
All activities must be conducted in line with Premier Research Policies and Standard Operating Procedures, other standard procedural documents that are contractually agreed for a given activity and all nationally and globally applicable laws, Regulations and Guidelines.