Clinical Lead III

Premier Research Group; Oregon; Hybrid; USD 110,000 - 134,000; Full time

Benefits offered by this job

Health insurance

Retirement plans

Paid time off

Job summary

Premier Research is seeking a Clinical Lead III to join the Clinical Management team. You will drive clinical delivery strategy, lead large SSU teams, and ensure alignment with customer budgets.

The role requires strong leadership, global regulatory knowledge, and excellence in communication. You will collaborate across functions to set up systems, monitor risk, and activate sites, while shaping recruitment strategies with CRAs to achieve enrollment targets.

Qualifications

• Bachelor's degree in a clinical, biological, scientific, or health-related field or equivalent work experience.
• 4 years of experience as a Clinical Lead with onsite monitoring experience preferred.
• Strong knowledge of global processes and regulations.
• Strong understanding of QA processes and controls.
• Excellent communication, presentation and soft skills to manage teams and sites.

Responsibilities

• Lead large clinical/SSU teams and align delivery with the customer’s expectations and study budget.
• Identify and mitigate protocol execution risks during Risk Assessment.
• Collaborate with PM and support functions to ensure clinical systems are set up, UAT’d, maintained andReporting needs.
• Coordinate with Regulatory Submissions Leads and Site Activation Leads to identify and activate sites within timelines and budget.
• Plan patient recruitment and retention strategies and partner with CRAs to meet enrollment targets.

Skills

Communication

Leadership

Stakeholder management

Education

Bachelor's degree in clinical/biological field

Tools

Risk-Based Monitoring

Job description

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 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 KOM meeting to ensure a strong and aligned SSU and clinical delivery strategy and the proposed study budget aligns with execution expectations of the customer. Effectively leads large clinical/SSU teams.
• Significantly contributes to the Risk Assessment meeting to identify any protocol execution risks or other Clinical/SSU operational risks.
• Contributes to cross functional strategy and problem solving by collaborating with PM and other support functions to ensure clinical systems are set up, UAT'd, maintained and supports project and reporting needs.
• Collaborates with SSU team (eg Regulatory Submissions Leads, Site Start Up Associates, Contracts Leads/Specialists and/or Site Activation Leads) 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.

What we're searching for:

• Bachelor's degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field; or equivalent work experience
• 4 years of experience as a Clinical Lead. Prior onsite monitoring experience including experience with Risk-Based Monitoring is preferred.
• Strong knowledge on global processes and regulations
• Strong understanding of other functional processes including QA.
• Excellent communication, presentation and soft skills to manage teams and sites effectively.
• Strong leadership skills including organizational skills, ability to persuade and motivate team members and sites to achieve targets.

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized minimum base pay for this role is $122,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.

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