Director Clinical Operations

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

Overview

The Director, Clinical Operations will provide oversee the execution of clinical trials within the development programs. The incumbent will serve as the governance contact for the CRO and clinical vendors, will ensure that all assigned operational trial deliverables are met according to timelines, budget, operational procedures, quality standards, SOPs and business guidelines.

Responsibilities

• Provides strategic input to the clinical development plan


• Develops the operational plans for trials within the assigned development program(s)


• Oversees trial execution team to ensure delivery of clinical trial within budget and agreed upon timelines


• Identifies and/or anticipates operational risks and mitigation plans across trials within the development program and escalates issues to senior management as necessary


• Manages the quality of work performed by direct reports (i.e. AD, CTM, CRA, and CTC) through regular review and evaluation of work product. Acting as a coach and mentor.


• Serves as the relationship manager for CRO/Vendors and is a member of the joint oversight committee


• Reviews CRO/Vendor agreements and negotiates the performance metrics to be outlined within the agreements


• Contributes to Global clinical / regulatory submissions


• May perform periodic visits to sites and/or vendors to assess progress and compliance


• Presents status reports of operational execution activities to senior management


• Ensure clinical trials maintain an inspection readiness state throughout the lifecycle of the trial

Qualifications

• 10 years of clinical operations experience in a pharmaceutical, biotech and/or contract research organization (CRO) setting; including management of a CRO.


• 7 years supervisory experience, 5 years direct project/trial management experience and 2 years in leadership role


• Strong collaborator with excellent communication skills; “Can do” attitude.


• Requires a BS in the health or life sciences or equivalent.


• Oncology experience is highly preferred.


• Experience with trial master file organization, regulatory documents, inspection preparation/readiness (site and Sponsor) required.


• Good working knowledge of the international conference on harmonization (ICH) and good clinical practice (GCP) guidelines and other applicable regulatory guidelines required; basic statistical knowledge preferred.


• Excellent computer skills (Microsoft Office Suite, Project, Outlook; Electronic Data Capture and Trial Master File Systems).


• Global Clinical Trial Experience and the ability to support more than one clinical trial is required.

Work Environment

The work is performed in a typical office environment with heavy computer duties.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually quiet.

Frequent travel required.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

No. of Vacancies

1

Job Nature

Full-time

Experience Requirements

10

Job Location

North Carolina, US

Job Level

Sr. Position