Clinical Lead II

Premier Research Group; United States; Teletrabalho; USD 57 000 - 70 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

Retirement plan

Paid time off

Employee Assistance Program

Resumo da oferta

Premier Research seeks a Clinical Lead II to join the Clinical Management team in the Oncology area. You will drive kickoff, risk assessment, site start-up collaboration, patient recruitment strategies, and contract review to ensure timely, compliant study delivery.

The role requires a Bachelor’s in a clinical or scientific field and at least two years of onsite monitoring experience, with RBM exposure preferred, to advance innovative therapies and patient outcomes.

Qualificações

• Bachelor’s degree in a clinical, biological, scientific, or health-related field, or equivalent work experience.
• 2 years of experience as a Clinical Lead; onsite monitoring experience with Risk-Based Monitoring preferred.
• Experience in Oncology therapeutic area is required.

Responsabilidades

• Contributes to Kick Off Meeting to align SSU and clinical delivery strategy with customer budgets.
• Contributes to Risk Assessment meeting to identify protocol execution risks and SSU operational risks.
• Collaborates with Site Start Up to identify, select, and activate sites within timeline and budget.
• Plans and oversees patient recruitment and retention strategies; partners with CRAs to hit enrollment targets.
• Reviews study contract and budget; ensures clinical team training on obligations and timelines.
• Works with Project Manager and Regulatory Submissions Lead to establish timelines and milestones.

Conhecimentos

Clinical Lead experience

Onsite monitoring

Risk-Based Monitoring

Oncology experience

Formação académica

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

Descrição da oferta de emprego

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 assesses any overburn.

What we are 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
• 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.

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The minimum annualized starting base pay for this role is 251,000 PLN. The actual salary will be influenced based on a variety of factors such as qualifications, skills, competencies, and proficiency for the role. We also offer comprehensive benefits packages, which may include health insurance, life insurance, retirement plan, paid time off, and an Employee Assistance Program.