Job Description
Job Description
Clinical Research Lead
Summary:
The Clinical Research Lead manages clinical trial operations, serving as a key contact for sites, vendors, and sponsors to ensure studies are executed efficiently and compliantly. Responsibilities include site identification and management, enrollment planning, data integrity, regulatory compliance, budget oversight, and leading and mentoring research staff to meet study timelines and objectives. A strong background in clinical trial management, leadership, and regulatory knowledge (like ICH/GCP) is essential.
Key Responsibilities
- Site Management:
- Identify and qualify clinical trial sites and investigators.
- Develop and manage site relationships throughout the study lifecycle.
- Monitor and ensure site compliance with protocols, regulations, and GCP.
- Facilitate site monitoring visits and audits.
- Operations & Execution:
- Oversee study startup, patient screening, enrollment, and closeout activities.
- Coordinate data collection and ensure data quality and accuracy.
- Manage study budgets, contracts, and vendor activities.
- Contribute to protocol development and clinical study report writing.
- Leadership & Communication:
- Provide leadership and direction to clinical research teams.
- Serve as a communication bridge between sites, sponsors, CROs, and internal teams.
- Mentor and train CRAs and other staff on study requirements and best practices.
- Develop and implement risk management plans and drive process improvements.
- Regulatory Compliance:
- Ensure studies are conducted in compliance with ICH/GCP guidelines and local regulations.
- Oversee the maintenance of Trial Master Files (TMF) to ensure inspection readiness.
- Facilitate Institutional Review Board (IRB) submissions and management.
Required Skills & Qualifications
- Experience:
A Bachelor's degree (or higher) in a scientific or healthcare-related field with several years of experience in clinical research, including leadership roles.
- Knowledge:
Extensive understanding of clinical trial regulations (e.g., FDA, ICH/GCP) and research methodologies.
- Management:
Strong project management and leadership skills to manage teams and deadlines.
- Technical:
Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems is often required.
- Interpersonal:
Exceptional communication, interpersonal, and negotiation skills for effective stakeholder collaboration.