Clinical Lead III

Premier Research is looking for a Clinical Lead III to join our Global 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.

What You'll Be Doing

• Acts as a leader driving global study and / or program clinical team and departmental engagement, maximizing the efficiencies of the clinical team across studies / program
• Oversight of clinical team tracking and analysis of open action items, protocol deviations and communication reports
• Completes / contributes to the review of the protocol / study design, informed consent forms, case report forms, and other study documents / plans, or delegates to the assigned CL
• Applies a risk-based quality management mindset, contributes to the risk management plan, and supports setup of adaptive risk monitoring system with the study team as applicable
• Works with all functional leads and sponsor to identify data related issues and risks to clinical activities; assists CLs in the development of mitigation plans to minimize risk
• Supports the PM, regional CLs, and / or appropriate line managers to ensure team members are adequately resourced to the project for the entire duration of the study
• Oversight of financial health of clinical activities including support with identifying out-of-scope tasks from the Premier clinical team and ensures pre-approval of these tasks by the PM and Sponsor, as required

What We Are Searching For

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