Clinical Lead II - Rare Disease

Premier Research is looking for a Clinical Lead II - Rare Disease 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:

• Serves as initial point of contact for all site management and monitoring quality concerns, including initiation and oversight of site performance improvement plans (sPIP).

• Plans, presents and participates in sponsor calls, representing Clinical and SSU function by providing status updates on clinical deliverables.

• Oversees the quality of clinical monitoring, central monitoring and site management deliverables through the use of dashboards/reporting tools. Strong contributor to the central monitoring plan.

• Monitors clinical operations metrics, activities and timelines on a regular basis; Tracks data entry timelines, open actions, protocol deviations, queries aging reports, SDR/SDV backlog and monitoring visit report turnaround timelines.

• Ensures a state of audit readiness for both Premier and sites. Reviews/responds to audit findings and support sites in remediation/responses to any site audit findings.

• Escalates through the established channels CRA/CM/SSU performance concerns, quality events, data breaches, serious breaches, scientific misconduct or any other event that requires prompt assessment and reporting.

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

• Minimum 2 years of experience as a Clinical Lead. Prior onsite monitoring experience including experience with Risk-Based Monitoring is highly preferred.

• Required Therapeutic Area: Rare Disease as a Clinical Lead and Oncology

• Strong leadership skills including organizational skills, ability to persuade and motivate team members and sites to achieve targets.

• Working knowledge of clinical financials including understanding of budgets, pass- through and resource management

• Ability to multitask and work effectively in a fast-paced environment with changing priorities

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized minimum base pay for this role is $116,000.00 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