Premier Research
Clinical Lead II
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Premier Research is looking for a Clinical Lead II 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 here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- Your ideas influence the way we work, and your voice matters here.
- As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
What You'll Be Doing
- Significantly contributes to the Kick Off Meeting to ensure a strong and aligned SSU and clinical delivery strategy and the proposed study budget aligns with execution expectations of the customer.
- Significantly contributes to the Risk Assessment meeting to identify any protocol execution risks or other Clinical/SSU operational risks.
- Collaborates with Site Start Up team to ensure sites are identified, selected, approved by authorities/ethics committees and activated within the specified timeline/budget.
- Plans/oversees patient recruitment and retention strategies. Partners with CRAs to drive individual site enrollment targets.
- Reviews the study contract and budget to ensure clinical team members are trained on the contractual obligations, timelines and tasks.
- Collaborates with Project Manager and Regulatory Submissions Lead to establish clinical and SSU project timelines and milestones throughout the study.
- Plans, presents and participates in sponsor calls, representing Clinical and SSU function by providing status updates on clinical deliverables.
- Works with the PM and Project Financial Analyst (PFA) to forecast clinical and SSU units to assess any overburn.
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- Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field; or equivalent work experience.
- 2 years of experience as a Clinical Lead. Prior onsite monitoring experience including experience with Risk-Based Monitoring is preferred.
- This role is working within our Oncology Business Unit, so experience in this therapeutic area is required.
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