Strategic Director, Clinical Operations & Trials

Alpha Clinical Laboratory Inc; North Carolina; On-site; USD 150,000 - 210,000; Full time

Job summary

Alpha Clinical Laboratory Inc. in North Carolina seeks a Director, Clinical Operations to oversee clinical trial execution within development programs. The role acts as the governance contact for CROs and vendors, ensuring deliverables align with timelines, budgets, SOPs, and quality standards.

The position requires extensive CRO management experience, regulatory knowledge, and leadership of trial teams to maintain inspection readiness across the trial lifecycle.

Qualifications

• 10 years of clinical operations experience in pharma/biotech/CRO.
• Supervisory experience with leadership of trial teams.
• Experience with trial master file organization and regulatory docs.

Responsibilities

• Provides strategic input to the clinical development plan.
• Develops operational plans for trials within assigned programs.
• Oversees trial execution to ensure delivery within budget and timelines.
• Identifies operational risks and mitigations; escalates as needed.
• Manages quality of work of direct reports and mentors staff.
• Governs CRO/vendor relationships and oversees joint oversight committees.
• Contributes to global clinical/regulatory submissions.
• May visit sites/vendors to assess progress and compliance.
• Presents status reports on operational activities to senior management.
• Ensures inspection readiness throughout trial lifecycle.

Skills

Clinical operations

Supervisory experience

Project/trial management

Leadership

Oncology experience

Regulatory awareness

ICH/GCP knowledge

Statistical knowledge

Computer skills

Global clinical trials

Education

BS in health or life sciences

Tools

EDC systems

TMF systems

Microsoft Office

Project

Outlook

Job description

Alpha Clinical Laboratory Inc. in North Carolina seeks a Director, Clinical Operations to oversee clinical trial execution within development programs. The role acts as the governance contact for CROs and vendors, ensuring deliverables align with timelines, budgets, SOPs, and quality standards.

The position requires extensive CRO management experience, regulatory knowledge, and leadership of trial teams to maintain inspection readiness across the trial lifecycle.