Clinical Lead II

Premier Research International; Polska; On-site; PLN 226,000 - 276,000; Full time

Benefits offered by this job

Health insurance

Life insurance

Retirement plan

Paid time off

Employee Assistance Program

Job summary

Premier Research is seeking a Clinical Lead II to join the Clinical Management team in Poland. You will guide study delivery, manage site activation, recruitment, and risk mitigation while collaborating with PMs and regulatory leads to meet clinical milestones.

The role operates within the Oncology Business Unit and offers competitive compensation and comprehensive benefits. Minimum base pay is 251,000 PLN annually, with actual salary influenced by qualifications and experience.

Qualifications

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

Responsibilities

• Contribute to Kick Off Meeting to align SSU and clinical delivery strategy with customer budgets.
• Contribute to Risk Assessment meeting to identify protocol execution risks and operational risks.
• Collaborate with Site Start Up to identify, select and activate sites within timeline and budget.
• Plan and oversee patient recruitment and retention strategies; partner with CRAs on site enrollment targets.
• Review study contracts and budgets to train clinical team on obligations, timelines and tasks.
• Collaborate with Project Manager and Regulatory Submissions Lead to establish timelines and milestones.
• Present and participate in sponsor calls, providing status updates on clinical deliverables.
• Forecast clinical and SSU units with PM and PFA to monitor overburn.

Skills

Clinical Lead experience

Oncology experience

Onsite monitoring

Risk-Based Monitoring

Education

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

Job description

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.