Clinical Lead II

Premier Research Group; Polska; Presencial; PLN 226.000 - 276.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Retirement plan

Paid time off

Employee Assistance Program

Descripción de la vacante

Premier Research Group is seeking a Clinical Lead II to join our Clinical Management team in Poland. You will drive clinical delivery strategies for oncology studies and help transform scientific ideas into patient solutions.

You will contribute to kickoff and risk assessment meetings, coordinate site start-up, patient recruitment plans, and collaborations with PM and regulatory leads to ensure timely delivery and quality outcomes across studies.

Formación

• Bachelor’s degree or international equivalent in a clinical/biological/health-related field or equivalent work experience.
• 2 years of experience as a Clinical Lead with onsite monitoring preferred.
• Experience in Oncology is required.

Responsabilidades

• 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.

Conocimientos

Clinical Leadership

Oncology experience

Site monitoring

Risk-Based Monitoring

Recruitment planning

Educación

Bachelor’s degree or international equivalent in clinical/biological/health-related field

Descripción del empleo

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.