Project Manager Ii/Senior - Cell And Gene Therapy

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We’re a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.

What you’ll be doing:

• Successful management and coordination of efforts assigned to all members of the project team, including but not limited to Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall project delivery
• Adherence to project budget and scope of work to realize project profitability
• All project tasks completion in accordance with project plans and in compliance with global and consistent Premier Research processes, policies, and procedures
• Project risks identification and mitigation
• Effective communication, and project status reports and monthly progress reports are provided both internally and externally
• Compliance for project-related training
• Adequate resourcing to meet project deliverables and milestones
• Representation at client meetings along with commercial colleagues to help win new business

You’ll need this to be considered:

• Bachelor’s degree preferably in a clinical, biological or science-related field from an accredited college or university, or equivalent combination of education and experience
• Demonstrated clinical research experience
• Strong global project management experience, preferably with a CRO
• Gene and Cell Therapy experience is required
• Experience managing a study from start to completion, managing multiple phases, and managing the full project life cycle
• Budget/finance/costing experience on a project level
• Demonstrated understanding of therapeutic and protocol disciplines, ICH/GCP regulations, FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
• A highly confident and effective presenter, fluent in English with strong oral and written communication skills and proficiency with web-based communication tools

Why choose Premier Research?

• Premier Research is more than a company – it’s a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need.
• Our cultural anchors – Caring & Empathy, Empowerment, Aspiration, One Team – mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location.
• Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.

Because we are transforming life-changing ideas into new medical treatments for a diverse population, we require the perspectives of a diverse staff thinking creatively, challenging ideas, and solving complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we create a community of belonging that welcomes differences, fuels innovation, and better connects us to the patients, physicians, and customers we serve.

We hire people that add to our culture, then invest in developing skills and abilities. If you are excited about this role, but your past experiences do not perfectly align with the position as described, we encourage you to apply anyway. You may be exactly the right candidate for this role or others.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status.

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