Clinical Lead III

premierresearch; United States; On-site; 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 our Clinical Management team in the United States. You will contribute to defining study delivery strategies, budgets, and risk assessments, leading large clinical/SSU teams and collaborating across functions to ensure sites are activated on time.

The role requires a Bachelor's degree in a related field and 4 years of Clinical Lead experience, with preference for Risk-Based Monitoring familiarity and strong regulatory knowledge.

Qualifications

• Bachelor’s degree in a clinical, biological, scientific, or health-related field.
• 4 years of experience as a Clinical Lead.
• Onsite monitoring experience with Risk-Based Monitoring preferred.
• Strong knowledge of global processes and regulations.

Responsibilities

• 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.
• Significantly contributes to the Risk Assessment meeting to identify protocol execution risks or other Clinical/SSU operational risks.
• Collaborates 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 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 site enrollment targets.

Skills

Communication

Leadership

Presentation

Team management

Education

Bachelor's degree in clinical/biological/scientific/health-related field

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.