Senior Project Lead

at  Premier Research

Premier Research is looking for a Senior Project Lead to join our Functional Services team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
• We are Built by You. Your ideas influence the way we work, and your voice matters here.
• We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Together, we are Built for BiotechSM. Join us and build your future here.

What you’ll be doing:

• Provide oversight and project management of the planning, execution, and completion of clinical trials in accordance with all applicable regulations and guidance including ICH/GCP
• Ensure successful management and coordination of efforts assigned to all members of the clinical operations project team, including but not limited to Regulatory, Drug Safety, to support milestone achievement and overall project delivery
• Oversee and facilitate the development and review of project documentation, including but not limited to, Case Report Forms, Source Documents, and study plans
• Provide clinical operations oversight in the evaluation and selection of investigative sites and vendors (e.g. – central labs, IVRS, etc)
• Oversee study financial health, participating in the forecasting of study-related costs and monitoring against study budget
• Create and maintain in a timely fashion a study specific clinical monitoring plan (CMP) utilizing approved templates; ensures effective communication and escalation instructions are incorporated in the CMP and actioned appropriately

What we’re searching for:

• Bachelor’s degree, or its international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field; or equivalent combination of education, training, and experience
• 7-9 years of clinical research experience, including 2 years of study management experience and 5 years of clinical monitoring or clinical management experience
• Strong analytical and organization skills, able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities

Premier Research is looking for a Senior Project Lead to join our Functional Services team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
• We are Built by You. Your ideas influence the way we work, and your voice matters here.
• We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for

What you’ll be doing:

• Provide oversight and project management of the planning, execution, and completion of clinical trials in accordance with all applicable regulations and guidance including ICH/GCP
• Ensure successful management and coordination of efforts assigned to all members of the clinical operations project team, including but not limited to Regulatory, Drug Safety, to support milestone achievement and overall project delivery
• Oversee and facilitate the development and review of project documentation, including but not limited to, Case Report Forms, Source Documents, and study plans
• Provide clinical operations oversight in the evaluation and selection of investigative sites and vendors (e.g. – central labs, IVRS, etc)
• Oversee study financial health, participating in the forecasting of study-related costs and monitoring against study budget
• Create and maintain in a timely fashion a study specific clinical monitoring plan (CMP) utilizing approved templates; ensures effective communication and escalation instructions are incorporated in the CMP and actioned appropriatel