Clinical Lead II (Dermatology)

Premier Research helps biotech, medtech, and specialty pharma companies develop medicines, devices, and diagnostics that improve patients’ lives. The Clinical Lead II will oversee clinical monitoring, site management, study quality, performance metrics, audit readiness, and escalation of clinical operations concerns in dermatology programs.

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

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

Preferred

Prior onsite monitoring experience including experience with Risk-Based Monitoring is highly preferred

Onsite Monitoring

Risk-Based Monitoring

Benefits

Health insurance

Retirement plans

Paid time off

Company

Global clinical research and consulting services for life sciences.

Morrisville, North Carolina, USA

https://premier-research.com/

Founded in 1989

1001-5000 employees

Qualifications

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

Required Therapeutic Area: Dermatology

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

Prior onsite monitoring experience including experience with Risk-Based Monitoring is highly preferred

2 years of experience as a Clinical Lead.

Required skills

Represents the skills you have, click on the tags, Risk-Based Monitoring, Clinical Financial Management, Persuasion and Motivation

Experience

2+ years