Clinical Lead II to join our Clinical Management team.
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.
