Associate Director, Clinical Operations Lead
Code: 36092
Posted: 2026-04-27
Type: Contract
Remote: Yes
Salary Range: $165,000 - $175,000 Per Year
Category: Clinical Operations
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Job Overview
The Associate Director, Clinical Operations Lead is responsible for the operational strategy and the comprehensive delivery of assigned clinical studies and/or programs. This role involves leading cross-functional teams in a matrix environment, ensuring high-quality execution, adherence to budget and timelines, effective vendor oversight, and regulatory compliance across studies ranging from low to moderately complex to highly complex global trials.
For select lower to moderately complex studies, the AD COL may take on strategic and day-to-day operational leadership, serving simultaneously as the SET Leader and SET Manager.
Key Responsibilities
- Own and drive the clinical operations strategy, providing early input into Clinical Development Plans (CDP) and study design.
- Lead cross-functional study teams, ensuring end-to-end execution from protocol development through CSR and TMF archiving.
- Serve as the primary contact for study-related matters; manage senior internal and external stakeholders and represent Clinical Operations in governance forums.
- Accountable for vendor/CRO strategy, oversight, and contract alignment with Business Operations.
- Enhance budget strategy, forecasts, timelines, and resource optimization; monitor and report on key study performance metrics.
- Identify and manage operational risks, escalate issues for resolution, and support audits and inspections.
- Define and oversee site engagement strategies, feasibility, and enrollment forecasting.
- Provide functional leadership, coaching, and mentorship across Clinical Operations; contribute to SOPs, process improvements, and knowledge sharing.
- Ensure appropriate delegation and inter-study efficiencies when overseeing multiple studies or a program.
- Maintain current knowledge of the therapeutic area/product candidates, clinical practices, competitors, and regulatory considerations.
Essential Requirements
- A minimum of 10 years of relevant clinical research experience within the pharmaceutical industry.
- Previous experience leading and managing a team of professionals.
- A solid understanding of the drug development process, particularly each step within the clinical trial process.
- Experience overseeing large and/or complex global clinical trials.
- Robust experience in budget forecasting and management.
- Thorough knowledge of ICH guidelines and GCP as applicable to all stages of the clinical development process.
Full-time employees are also eligible for benefits such as health coverage, life insurance, disability insurance, and 401(k) benefits.
At Advanced Group, our commitment to diversity and inclusion is crucial to fulfilling our mission and demonstrating our REAL values. We are dedicated to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state, or local law.
Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities.
Apply online using the form below.