Clinical Lead III

at  Premier Research

Premier Research is looking for a Clinical Lead III to join our Clinical Management 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 medical innovation that patients are desperate for.

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

What you’ll be doing:

• Provides coaching and mentoring to clinical staff, study team and external stakeholders and serve as initial point of contact and Ambassador for Clinical Management Group to internal and external stakeholders
• Leads, manages and actively monitors the clinical monitoring team with a focus on ensuring quality and timely deliverables, addressing any issues with the appropriate team member and their line manager
• Drives the successful activation of trial sites according to time, quality/scope and budget parameters, including completing/contributing to the review of the protocol/study design, informed consent forms and be a reference point for CRAs and investigative sites and applying clinical and monitoring expertise in the design of case report forms
• Create and maintain in a timely fashion a study specific clinical monitoring plan (CMP), tracking and analyzing open actions, protocol deviations and assessing the financial health of the clinical aspect of the study ensuring effective communication and escalation instructions are incorporated in the CMP and actioned appropriately
• Engages cross functionally to deliver project deliverables with PM, Data Managers (DM), Clinical Monitoring Services team (CMS) to identify data related issues and risks to clinical activities; assist in the development of mitigation plans to minimize risk; plan and drive both patient recruitment and retention; ensure transparent and proactive sponsor and internal communication regarding study progress and trial issues; establish clinical project timelines and accomplish all milestones throughout the study; and assist in the creation and maintenance of the Trial Master File

Premier Research is looking for a Clinical Lead III to join our Clinical Management 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 medical innovation that patients are desperate for

What you’ll be doing:

• Provides coaching and mentoring to clinical staff, study team and external stakeholders and serve as initial point of contact and Ambassador for Clinical Management Group to internal and external stakeholders
• Leads, manages and actively monitors the clinical monitoring team with a focus on ensuring quality and timely deliverables, addressing any issues with the appropriate team member and their line manager
• Drives the successful activation of trial sites according to time, quality/scope and budget parameters, including completing/contributing to the review of the protocol/study design, informed consent forms and be a reference point for CRAs and investigative sites and applying clinical and monitoring expertise in the design of case report forms
• Create and maintain in a timely fashion a study specific clinical monitoring plan (CMP), tracking and analyzing open actions, protocol deviations and assessing the financial health of the clinical aspect of the study ensuring effective communication and escalation instructions are incorporated in the CMP and actioned appropriately
• Engages cross functionally to deliver project deliverables with PM, Data Managers (DM), Clinical Monitoring Services team (CMS) to identify data related issues and risks to clinical activities; assist in the development of mitigation plans to minimize risk; plan and drive both patient recruitment and retention; ensure transparent and proactive sponsor and internal communication regarding study progress and trial issues; establish clinical project timelines and accomplish all milestones throughout the study; and assist in the creation and maintenance of the Trial Master Fil