Clinical Lead II (Oncology)

About the role

Premier Research is seeking a Clinical Lead II (Oncology) to join our Clinical Management team. This role involves transforming life-changing ideas and breakthrough science into new medicines, devices, and diagnostics for biotech, medtech, and specialty pharma companies. The position is crucial for delivering medical innovation that patients desperately need.

Responsibilities

• 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.
• Maintains clinical operations metrics, activities, and timelines; tracks data entry timelines, open actions, protocol deviations, queries aging reports, SDR/SDV backlog, and monitoring visit report turnaround timelines.
• Ensures audit readiness for both Premier and sites, reviews/responds to audit findings, and supports sites in remediation/responses to any audit findings.
• Escalates through established channels for CRA/CM/SSU performance concerns, quality events, data breaches, serious breaches, scientific misconduct, or any other event requiring prompt assessment and reporting.

Requirements

• 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.
• Required Therapeutic Area: 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.

Qualifications

Must have a Bachelor’s degree or equivalent work experience, 2 years of experience as a Clinical Lead, and prior onsite monitoring experience, including experience with Risk-Based Monitoring. Required Therapeutic Area: 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.

Skills

Leadership skills, 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.

Benefits

Comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.

Pay

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.

Schedule

Not specified.